Cleared Traditional

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL

K946145 · Clinical Controls, Inc. · Chemistry
Jan 1995
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K946145 is an FDA 510(k) clearance for the CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on January 24, 1995, 39 days after receiving the submission on December 16, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K946145 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1994
Decision Date January 24, 1995
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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