ANALYZER, IMPACT 200

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

GILFORD INSTRUMENT LABORATORIES, INC.

The following data is part of a premarket notification filed by Gilford Instrument Laboratories, Inc. with the FDA for Analyzer, Impact 200.

Pre-market Notification Details

Device IDK790072
510k NumberK790072
Device Name:ANALYZER, IMPACT 200
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant GILFORD INSTRUMENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-11
Decision Date1979-02-22

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