Cleared Traditional

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

K883305 · Binax, Inc. · Chemistry
Oct 1988
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K883305 is an FDA 510(k) clearance for the BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on October 6, 1988, 63 days after receiving the submission on August 4, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K883305 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1988
Decision Date October 06, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGJ — Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1300

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