Cleared Traditional

SLIDE PREGNANCY TEST

K842110 · Immunostics Co., Inc. · Chemistry
Jul 1984
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K842110 is an FDA 510(k) clearance for the SLIDE PREGNANCY TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Immunostics Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984, 44 days after receiving the submission on May 29, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K842110 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1984
Decision Date July 12, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHJ — Agglutination Method, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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