URINE SCREENING KIT

Dye-indicator, Ph (urinary, Non-quantitative)

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Urine Screening Kit.

Pre-market Notification Details

Device IDK830824
510k NumberK830824
Device Name:URINE SCREENING KIT
ClassificationDye-indicator, Ph (urinary, Non-quantitative)
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCEN  
CFR Regulation Number862.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-15
Decision Date1983-06-12

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