KD ONE-STAGE PROTHROMBIN TIME TEST

System, Multipurpose For In Vitro Coagulation Studies

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Kd One-stage Prothrombin Time Test.

Pre-market Notification Details

Device IDK883640
510k NumberK883640
Device Name:KD ONE-STAGE PROTHROMBIN TIME TEST
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances Loh
CorrespondentFrances Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-25
Decision Date1988-10-31

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