QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.

C-reactive Protein, Antigen, Antiserum, And Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric 2 C-reactive Protein Reag..

Pre-market Notification Details

Device IDK821984
510k NumberK821984
Device Name:QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-06
Decision Date1982-07-22

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