Cleared Traditional

FSH RADIOIMMUNOASSAY TEST SYSTEM

K820048 · Monobind · Chemistry
Feb 1982
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K820048 is an FDA 510(k) clearance for the FSH RADIOIMMUNOASSAY TEST SYSTEM, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982, 27 days after receiving the submission on January 8, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K820048 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1982
Decision Date February 04, 1982
Days to Decision 27 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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