Cleared Traditional

FIRST RESPONSE 5 MINUTE PREGNANCY TEST

K874823 · Tambrands, Inc. · Chemistry
Apr 1988
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K874823 is an FDA 510(k) clearance for the FIRST RESPONSE 5 MINUTE PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on April 5, 1988, 133 days after receiving the submission on November 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K874823 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1987
Decision Date April 05, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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