COATEST(R) APC(TM) RESISTANCE

Test, Time, Partial Thromboplastin

AXIS-SHIELD DOC AS

The following data is part of a premarket notification filed by Axis-shield Doc As with the FDA for Coatest(r) Apc(tm) Resistance.

Pre-market Notification Details

Device IDK945940
510k NumberK945940
Device Name:COATEST(R) APC(TM) RESISTANCE
ClassificationTest, Time, Partial Thromboplastin
Applicant AXIS-SHIELD DOC AS P.O. BOX 262069 San Diego,  CA  92196 -2069
ContactRonald G Leonardi
CorrespondentRonald G Leonardi
AXIS-SHIELD DOC AS P.O. BOX 262069 San Diego,  CA  92196 -2069
Product CodeGGW  
CFR Regulation Number864.7925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-05
Decision Date1995-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950088929 K945940 000
08426950088912 K945940 000
08426950060147 K945940 000

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