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510(k) Data Aggregation
K Number
K984384Device Name
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
Manufacturer
Date Cleared
1998-12-23
(15 days)
Product Code
Regulation Number
862.1120Why did this record match?
Applicant Name (Manufacturer) :
THERMO BIOANALYSIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such. ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics.
The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers sample flow path. The products encompassed are to be handled using normal laboratory precautions.
Device Description
The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions I he products chooligable of assis Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. Chiron Diagnostics (formally Ciba-Corning) is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.
ALKO manufactures the buffer reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also pri (6.nouther the Wash Solution. The ALKO Reagents are intended to serve as direct replacements to like named oroducts manufactured by Chiron Diagnostics. The Buffer Pack which consists of one bottle each of 6.8 and 7.3 Buffer, are Buffered Solutions for calibration of the pH electrode. The Wash Solution is used to rinse the analyzers sample flow path.
- ALKO product A473-496 (6.8 / 7.3 Buffer Pack) is equivalent to Chiron Diagnostics product 473496 . (6.8 / 7.3 Buffer Pack).
- ALKO Product A473-497 (Wash Solution), is equivalent to Chiron Diagnostics product 473497 . (Wash Solution).
ALKO uses a similar composition and packaging design as that used by Chiron Diagnostics in its products.
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K Number
K981795Device Name
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO
Manufacturer
Date Cleared
1998-06-12
(22 days)
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
THERMO BIOANALYSIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen.
The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products encompassed are to be handled using normal laboratory precautions.
Device Description
The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent ABL™ pH/ Blood Gas Analyzers. Radiometer Medical/Copenhagen is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.
ALKO manufactures the calibration reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Radiometer Medical /Copenhagen. The Calibration Solutions, pH 7.4/3 and Calibration Solution, pH 6.8/4 are buffered solutions for calibration of the pH electrode. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode and the sample during calibration and measurement. The Cleaning Solution /S and Hypochlorite olution are all used to clean and rinse the analyzers electrodes, and sample flow path.
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