Cleared Traditional

VISUAL HCG PREGNANCY TEST

K923376 · Tech-Co, Inc. · Chemistry
Oct 1992
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K923376 is an FDA 510(k) clearance for the VISUAL HCG PREGNANCY TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Tech-Co, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on October 1, 1992, 84 days after receiving the submission on July 9, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K923376 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1992
Decision Date October 01, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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