Cleared Traditional

DIRECT PREGNANCY TEST

K920716 · Tech-Co, Inc. · Chemistry
Mar 1992
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K920716 is an FDA 510(k) clearance for the DIRECT PREGNANCY TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Tech-Co, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on March 24, 1992, 35 days after receiving the submission on February 18, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K920716 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1992
Decision Date March 24, 1992
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHJ — Agglutination Method, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155