510(k) K023992
- Device
- WIENER LAB COLINESTERASA AA
- Applicant
- WIENER LABORATORIES S.A.I.C.
- 510(k) number
- K023992
- Product code
- DIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-12
- Date received
- 2002-12-02
- Regulation
- 862.3240
- Classification name
- Colorimetry, Cholinesterase
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIANA CETOLA
- Address
- 2571 Maipu Rosario, Santa Fe AR 2000 2000
FDA Registration Numbers#
- 8040374
- 2517506
- 3006198300
- 3004493545
- 9680746
- 3000308930
- 2085064
- 3003502294
- 3010825766
- 3002642396
- 9610126
- 3003795116
- 1319809
- 1181121
- 3012963943
- 1832216
- 2250051
- 2050012
- 9610529
- 3014325803
- 2050010
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code DIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K103373 | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | Beckman Coulter, Inc. | 2011-02-07 |
| K061093 | CHOLINESTERASE GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-03 |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | Sentinel Ch. Srl | 2005-06-20 |
| K030045 | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | Olympus America, Inc. | 2003-02-21 |
| K013750 | ADVIA 1650 CHOLINESTERASE ASSAY | Bayer Diagnostics Corp. | 2002-01-18 |
| K002792 | CARESIDE CHOLINESTERASE | Careside, Inc. | 2000-11-08 |
| K001344 | ADVIA IMS | Bayer Corp. | 2000-06-26 |
| K961656 | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM | Eqm Research, Inc. | 1996-11-26 |
| K943367 | IL TEST CHOLINESTERASE | Instrumentation Laboratory CO | 1996-02-05 |
| K955498 | CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 | Diagnostic Chemicals , Ltd. | 1996-01-24 |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | Tech Intl. Co. | 1991-12-18 |
| K913198 | KODAK EKTACHEM DT SLIDES (CHE) | Eastman Kodak Company | 1991-08-26 |
| K912148 | CHOLINESTERASE TEST KIT | Crestat Diagnostics, Inc. | 1991-08-12 |
| K912217 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1991-07-01 |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | Beckman | 1989-08-15 |
Legacy Summary#
summary
FDA Review#
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