WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k) clearance K013095 · decided 2001-11-16
Clearance details
- K-number
- K013095
- Device name
- WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
- Applicant
- Wiener Laboratories Saic
- Decision
- Substantially Equivalent
- Date received
- 2001-09-17
- Decision date
- 2001-11-16
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- CEO
- Device class
- 1
- Regulation number
- 862.1580
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rosario, Santa Fe, AR
- Third-party review
- No
- Expedited review
- No
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| PICCOLO PHOSPHORUS TEST SYSTEM (K022312) | Abaxis, Inc. | 2002-09-05 |
| PHOSPHORUS REAGENT (K003912) | Jas Diagnostics, Inc. | 2001-02-21 |
| RAICHEM PHOSPORUS REAGENT (K003012) | Hemagen Diagnostics, Inc. | 2000-10-25 |
| INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867) | A.P. Total Care, Inc. | 1999-08-02 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503) | Boehringer Mannheim Corp. | 1998-12-01 |
| HICHEM PHOSPHORUS REAGENT KIT (K981769) | Elan Pharma, Inc. | 1998-06-29 |
| CARESIDE ANALYZER (K981610) | Careside, Inc. | 1998-06-25 |
| PHOS (K981759) | Abbott Laboratories | 1998-06-16 |
Recalls involving this device
No recalls on record reference this clearance.