Cleared Traditional

LH IRMA IMMUNOMAG

K911050 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Apr 1991
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K911050 is an FDA 510(k) clearance for the LH IRMA IMMUNOMAG, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on April 12, 1991, 35 days after receiving the submission on March 8, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K911050 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1991
Decision Date April 12, 1991
Days to Decision 35 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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