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510(k) Data Aggregation
K Number
K961803Device Name
SPUNCRIT (MODEL DRC-40)
Manufacturer
MICRO DIAGNOSTICS CORP.
Date Cleared
1996-07-05
(57 days)
Product Code
GKG
Regulation Number
864.6400Why did this record match?
Product Code :
GKG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Micro Hematocrit Centrifuge
Operations Manual
Battery Charger
100 Micro Capillary/Micro Capillary Holders (heparinized)
General Laboratory Device
Methodology: Centrifugal
Measures Hematocrit
Battery Operated
Portable, Hand-Held
Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) Motor failure indicator
Optically read (digital readout)
Uses plastic disposable
Range 14% to 57%
Operates at 10,000 RPM
RCF= 4260
Rotor Radius= 1.5 inches
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K Number
K955795Device Name
MULTI-CENTRIFUGE
Manufacturer
NOVONX, INC.
Date Cleared
1996-03-29
(98 days)
Product Code
GKG
Regulation Number
864.6400Why did this record match?
Product Code :
GKG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Multi-Centrifuge is a device that includes a centrifuge and a manual hematocrit reader. The hematocrit reader utilizes various distances to calculate a ratio (Hct) of Red Blood Cells to blood sample volume. These distances are at key separation (interface) points marked by the user. The device uses a flat disk rotor, resulting in interface points that are perpendicular to the hematocrit tube length. The marked interface points are Sealant/Red Blood Cells (Point A), Red Blood Cells/Plasma (Point B), and Plasma/Air (Point C). A microprocessor uses the equation (A + B) / (A + C) x 100 to calculate the ratio. The device has a larger LCD display compared to the predicate device.
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