Cleared Traditional

STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY

K873052 · American Dade · Chemistry
Sep 1987
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K873052 is an FDA 510(k) clearance for the STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on September 14, 1987, 41 days after receiving the submission on August 4, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K873052 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1987
Decision Date September 14, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEP — Radioimmunoassay, Luteinizing Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485

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