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Found 3 results
510(k) Data Aggregation
K Number
K990971Device Name
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
Manufacturer
MEDICA CORP.
Date Cleared
1999-04-27
(35 days)
Product Code
JJR
Regulation Number
862.1660Why did this record match?
Product Code :
JJR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Assayed EasyLyte Quality Control Kit is intended for use with IV trolyte and yers to estimate test imprecision and to detects variation. eagent
Device Description
EasyLyte Quality Control Kit
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K Number
K960592Device Name
ELECTROLYTE STANDARDS
Manufacturer
PHOENIX DIAGNOSTICS, INC.
Date Cleared
1996-05-13
(91 days)
Product Code
JJR
Regulation Number
862.1660Why did this record match?
Product Code :
JJR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955630Device Name
RNA MEDICAL HEMAT CONTROL
Manufacturer
BIONOSTICS, INC.
Date Cleared
1996-03-01
(81 days)
Product Code
JJR
Regulation Number
862.1660Why did this record match?
Product Code :
JJR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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