Cleared Traditional

IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

K921968 · Tech-Co, Inc. · Chemistry

Jun 1996

Decision

1523d

Days

Class 2

Risk

About This 510(k) Submission

K921968 is an FDA 510(k) clearance for the IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Tech-Co, Inc. (Placentia, US). The FDA issued a Cleared decision on June 28, 1996, 1523 days after receiving the submission on April 27, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K921968 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 1992
Decision Date	June 28, 1996
Days to Decision	1523 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement