Cleared Traditional

FOLLICLE STIMULATING HORMONE (FSH) KIT

K792063 · Cis Radiopharmaceuticals, Inc. · Immunology
Nov 1979
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K792063 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE (FSH) KIT, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979, 36 days after receiving the submission on October 15, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K792063 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1979
Decision Date November 20, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
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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