ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Dermatome

U. S. DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Activated Partial Thromboplastin Time Test.

Pre-market Notification Details

Device IDK862669
510k NumberK862669
Device Name:ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
ClassificationDermatome
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeGFD  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-14
Decision Date1986-10-03

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