Atlas FDA

TARGET(TM) CK-MB

FDA 510(k) clearance K890295 · decided 1989-08-15

Clearance details

K-number
K890295
Device name
TARGET(TM) CK-MB
Applicant
V-Tech, Inc.
Decision
Substantially Equivalent
Date received
1989-01-19
Decision date
1989-08-15
Days to decision
208 days
Clearance type
Traditional
Product code
JHY
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
El Monte, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Dimension Vista MMB Assay (K143720)Siemens Healthcare Diagnostics2015-09-18
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080)Medica Corporation2014-05-13
ELECSYS CK-MB STAT IMMUNOASSAY (K140404)Roche Diagnostics2014-05-08
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571)Roche Diagnostics2013-10-18
OLYMPUS CK-MB REAGENT (K070835)Olympus Life & Material Science Europa GmbH (Irish2007-06-04
SPIFE CK KIT, MODEL 3332, 3333 (K022757)Helena Laboratories2002-10-11
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654)Roche Diagnostics Corp.2002-08-29
ELECSYS CK-MB STAT (K974421)Boehringer Mannheim Corp.1997-12-17
MMB METHOD (K970343)Dade Chemistry Systems, Inc.1997-02-14
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412)Bayer Corp.1996-06-18
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638)Organon Teknika Corp.1995-05-02
IMX(R) STAT CK-MB (K931172)Abbott Laboratories1993-06-15

Recalls involving this device

No recalls on record reference this clearance.