BHCG-CHECK

Agglutination Method, Human Chorionic Gonadotropin

DIAGNOSTIC TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Bhcg-check.

Pre-market Notification Details

Device IDK834346
510k NumberK834346
Device Name:BHCG-CHECK
ClassificationAgglutination Method, Human Chorionic Gonadotropin
Applicant DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHJ  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-12
Decision Date1984-02-04

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