Cleared Traditional

IMMULITE(TM) HCG

K911796 · Cirrus Diagnostics, Inc. · Chemistry
Jun 1991
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K911796 is an FDA 510(k) clearance for the IMMULITE(TM) HCG, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on June 20, 1991, 59 days after receiving the submission on April 22, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K911796 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1991
Decision Date June 20, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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