Cleared Traditional

B-SLIDE PREGNATE PREGNANCY TEST KIT

K832879 · Fisher Scientific Co., LLC · Chemistry
Oct 1983
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K832879 is an FDA 510(k) clearance for the B-SLIDE PREGNATE PREGNANCY TEST KIT, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 63 days after receiving the submission on August 26, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K832879 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1983
Decision Date October 28, 1983
Days to Decision 63 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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