C-REACTIVE PROTEIN TEST KIT

Calibrator, Primary

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for C-reactive Protein Test Kit.

Pre-market Notification Details

Device IDK822332
510k NumberK822332
Device Name:C-REACTIVE PROTEIN TEST KIT
ClassificationCalibrator, Primary
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-04
Decision Date1982-08-16

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