510(k) K023744
- Device
- WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
- Applicant
- WIENER LABORATORIES S.A.I.C.
- 510(k) number
- K023744
- Product code
- JHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-03
- Date received
- 2002-11-07
- Regulation
- 862.1215
- Classification name
- U.v. Method, Cpk Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIANA CETOLA
- Address
- 2944 Riobamba Rosario, Santa Fe AR 2000 2000
FDA Registration Numbers#
- 8040374
- 1616487
- 1827821
- 2050010
- 3007662974
- 2050012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162526 | Creatine Kinase-MB | Roche Diagnostics | 2017-05-26 |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Elitechgroup | 2014-07-18 |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Elitechgroup | 2012-08-22 |
| K003158 | ROCHE DIAGNOSTICS CK-MB | Roche Diagnostics Corp. | 2000-12-18 |
| K961501 | ELECSYS CK-MB | Boehringer Mannheim Corp. | 1996-06-11 |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-03-13 |
| K944325 | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN | Princeton BioMeditech Corp. | 1995-02-22 |
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Biochemical Trade, Inc. | 1994-11-21 |
| K935924 | AXSYM CK-MB | Abbott Laboratories | 1994-06-21 |
| K931050 | CARDIO REP CK ISOENZYME KIT - 3310 | Helena Laboratories | 1993-04-20 |
| K913349 | STAMBI-CK | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 |
| K905588 | CREATINE KINASE UV REAGENT SET | Biochemical Trade, Inc. | 1991-01-17 |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Intl. Immunoassay Laboratories, Inc. | 1990-09-07 |
| K883222 | ISOFOR-MM (TM) | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 |
Legacy Summary#
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FDA Review#
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