Cleared Traditional

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

K921763 · Hybritech, Inc. · Chemistry
Jun 1992
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K921763 is an FDA 510(k) clearance for the TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on June 9, 1992, 56 days after receiving the submission on April 14, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K921763 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1992
Decision Date June 09, 1992
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — JHY Colorimetric Method, Cpk Or Isoenzymes

All 39
Dimension Vista MMB Assay
K143720 · Siemens Healthcare Diagnostics · Sep 2015
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
K130080 · Medica Corporation · May 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · Roche Diagnostics · May 2014
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics · Oct 2013
OLYMPUS CK-MB REAGENT
K070835 · Olympus Life & Material Science Europa GmbH (Irish · Jun 2007
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002