GESTATE SLIDE EIKEN KIT AGG. METHOD HUM

Agglutination Method, Human Chorionic Gonadotropin

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Gestate Slide Eiken Kit Agg. Method Hum.

Pre-market Notification Details

Device IDK802450
510k NumberK802450
Device Name:GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
ClassificationAgglutination Method, Human Chorionic Gonadotropin
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJHJ  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1980-10-31

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