Cleared Traditional

TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

K894761 · Hybritech, Inc. · Chemistry
Sep 1989
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K894761 is an FDA 510(k) clearance for the TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 13, 1989, 48 days after receiving the submission on July 27, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K894761 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1989
Decision Date September 13, 1989
Days to Decision 48 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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