Cleared Traditional

K832599 - EARLY IN HOME PREGNANCY TEST
(FDA 510(k) Clearance)

K832599 · Warner-Lambert Co. · Chemistry

Sep 1983

Decision

49d

Days

Class 2

Risk

K832599 is an FDA 510(k) clearance for the EARLY IN HOME PREGNANCY TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 49 days after receiving the submission on August 2, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K832599 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1983
Decision Date	September 20, 1983
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—