CHEMISTRY ANALYZER, GEN. PURPOSE

Colorimeter, Photometer, Spectrophotometer For Clinical Use

HML INC/BIOTECHNOLOGY TRANSFER

The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Chemistry Analyzer, Gen. Purpose.

Pre-market Notification Details

Device IDK842311
510k NumberK842311
Device Name:CHEMISTRY ANALYZER, GEN. PURPOSE
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant HML INC/BIOTECHNOLOGY TRANSFER 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-12
Decision Date1984-07-25

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