Cleared Traditional

CRP LIPID REAGENT TEST PACK

K905648 · Cirrus Diagnostics, Inc. · Chemistry
Mar 1991
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K905648 is an FDA 510(k) clearance for the CRP LIPID REAGENT TEST PACK, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on March 6, 1991, 79 days after receiving the submission on December 17, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K905648 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1990
Decision Date March 06, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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