Cleared Traditional

FOLLICLE STIMULATING HORMONE (HFSH)

K871317 · Immuchem Corp. · Chemistry
May 1987
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K871317 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE (HFSH), a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on May 20, 1987, 48 days after receiving the submission on April 2, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K871317 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1987
Decision Date May 20, 1987
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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