Cleared Traditional

FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT

K844347 · Fisher Diagnostics · Chemistry
Jan 1985
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K844347 is an FDA 510(k) clearance for the FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Fisher Diagnostics. The FDA issued a Cleared decision on January 23, 1985, 75 days after receiving the submission on November 9, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K844347 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1984
Decision Date January 23, 1985
Days to Decision 75 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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