QUIK-DOT C REACTIVE PROTEIN

C-reactive Protein, Antigen, Antiserum, And Control

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Quik-dot C Reactive Protein.

Pre-market Notification Details

Device IDK892119
510k NumberK892119
Device Name:QUIK-DOT C REACTIVE PROTEIN
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
ContactRaymond Gould
CorrespondentRaymond Gould
AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-31
Decision Date1989-04-14

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