Cleared Traditional

STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY

K873051 · American Dade · Chemistry
Oct 1987
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K873051 is an FDA 510(k) clearance for the STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on October 20, 1987, 77 days after receiving the submission on August 4, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K873051 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1987
Decision Date October 20, 1987
Days to Decision 77 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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