510(k) K013095
- Device
- WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
- Applicant
- WIENER LABORATORIES S.A.I.C.
- 510(k) number
- K013095
- Product code
- CEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-16
- Date received
- 2001-09-17
- Regulation
- 862.1580
- Classification name
- Phosphomolybdate (colorimetric), Inorganic Phosphorus
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIANA CETOLA
- Address
- 2944 Riobamba Rosario, Santa Fe AR 2000 2000
FDA Registration Numbers#
- 8040374
- 8020316
- 3006716639
- 2030861
- 2517506
- 3016438761
- 3005333358
- 3006198300
- 3013660430
- 3004493545
- 3011989923
- 9680746
- 2085064
- 1616487
- 3002809144
- 3010825766
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 9610126
- 3003795116
- 1319809
- 1181121
- 2939693
- 1832216
- 3021841051
- 1827821
- 2247288
- 2050012
- 9610529
- 3014325803
- 2050010
- 3007662974
- 1181055
- 3003741796
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code CEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | Seppim S.A.S. | 2011-05-06 |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | Beckman Coulter, Inc. | 2004-08-18 |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Elan Diagnostics | 2003-03-07 |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | Abaxis, Inc. | 2002-09-05 |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | 2001-02-21 |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | 2000-10-25 |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-08-02 |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Boehringer Mannheim Corp. | 1998-12-01 |
| K981769 | HICHEM PHOSPHORUS REAGENT KIT | Elan Pharma, Inc. | 1998-06-29 |
| K981610 | CARESIDE ANALYZER | Careside, Inc. | 1998-06-25 |
| K981759 | PHOS | Abbott Laboratories | 1998-06-16 |
| K981118 | PHOS | Abbott Laboratories | 1998-06-12 |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | 1998-01-30 |
| K974605 | RANDOX INORGANIC PHOSPHOROUS | Randox Laboratories, Ltd. | 1998-01-09 |
Legacy Summary#
summary
FDA Review#
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