AMMONIA/IRON STANDARD KIT

Calibrator, Multi-analyte Mixture

VERICHEM LABORATORIES, INC.

The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Ammonia/iron Standard Kit.

Pre-market Notification Details

Device IDK972333
510k NumberK972333
Device Name:AMMONIA/IRON STANDARD KIT
ClassificationCalibrator, Multi-analyte Mixture
Applicant VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence,  RI  02907
ContactAnthony J Dimonte
CorrespondentAnthony J Dimonte
VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence,  RI  02907
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-23
Decision Date1997-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852553007377 K972333 000
00852553007353 K972333 000
00852553007261 K972333 000
00852553007216 K972333 000
00852553007087 K972333 000

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