Cleared Traditional

STAMBI-CK

K913349 · Intl. Immunoassay Laboratories, Inc. · Chemistry
Oct 1991
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K913349 is an FDA 510(k) clearance for the STAMBI-CK, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 23, 1991, 89 days after receiving the submission on July 26, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K913349 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1991
Decision Date October 23, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — JHW U.v. Method, Cpk Isoenzymes

All 26
Creatine Kinase-MB
K162526 · Roche Diagnostics · May 2017
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · Elitechgroup · Jul 2014
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · Elitechgroup · Aug 2012
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
K023744 · Wiener Laboratories Saic · Jan 2003
ROCHE DIAGNOSTICS CK-MB
K003158 · Roche Diagnostics Corp. · Dec 2000
ELECSYS CK-MB
K961501 · Boehringer Mannheim Corp. · Jun 1996