PHENYLALANINE UV KINETIC TEST KIT

Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine

BIOCHEMICALS, INC.

The following data is part of a premarket notification filed by Biochemicals, Inc. with the FDA for Phenylalanine Uv Kinetic Test Kit.

Pre-market Notification Details

Device IDK813171
510k NumberK813171
Device Name:PHENYLALANINE UV KINETIC TEST KIT
ClassificationNinhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
Applicant BIOCHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJNB  
CFR Regulation Number862.1555 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-16
Decision Date1981-12-03

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