Cleared Traditional

BRAND NAME *1-STEP PREGNANCY

K973352 · Armkel, LLC · Chemistry
Oct 1997
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K973352 is an FDA 510(k) clearance for the BRAND NAME *1-STEP PREGNANCY, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 27, 1997, 52 days after receiving the submission on September 5, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K973352 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1997
Decision Date October 27, 1997
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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