Cleared Traditional

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT

K895094 · Hybritech, Inc. · Chemistry
Oct 1989
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K895094 is an FDA 510(k) clearance for the TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 31, 1989, 78 days after receiving the submission on August 14, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K895094 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1989
Decision Date October 31, 1989
Days to Decision 78 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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