Cleared Traditional

K992232 - FIRST RESPONSE 1-STEP PREGNANCY
(FDA 510(k) Clearance)

K992232 · Armkel, LLC · Chemistry
Dec 1999
Decision
172d
Days
Class 2
Risk

K992232 is an FDA 510(k) clearance for the FIRST RESPONSE 1-STEP PREGNANCY. This device is classified as 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 December 21, 1999, 172 days after receiving the submission on July 2, 1999.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K992232 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1999
Decision Date December 21, 1999
Days to Decision 172 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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