Cleared Traditional

TBD AT-HOME PREGNANCY TEST

K961712 · Armkel, LLC · Chemistry
May 1996
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K961712 is an FDA 510(k) clearance for the TBD AT-HOME PREGNANCY TEST, 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 May 31, 1996, 29 days after receiving the submission on May 2, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K961712 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1996
Decision Date May 31, 1996
Days to Decision 29 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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