KOAGULAB 40-A AUTOMATED COAGULATION SYS

Instrument, Coagulation

ORTHO DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Koagulab 40-a Automated Coagulation Sys.

Pre-market Notification Details

Device IDK823131
510k NumberK823131
Device Name:KOAGULAB 40-A AUTOMATED COAGULATION SYS
ClassificationInstrument, Coagulation
Applicant ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria ,  CA  93013 -
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-25
Decision Date1982-12-09

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