URIC ACID (LIQUID) REAGENT SET
FDA 510(k) clearance K970560 · decided 1997-03-11
Clearance details
- K-number
- K970560
- Device name
- URIC ACID (LIQUID) REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1997-02-13
- Decision date
- 1997-03-11
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- KNK
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, 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.
| Record | Firm | Date |
|---|---|---|
| URIC ACID MODEL 3P39 (K102568) | Abbott Laboratories | 2011-05-06 |
| OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (K062862) | Olympus America, Inc. | 2007-04-06 |
| VITALAB URIC ACID REAGENT (K040467) | Clinical Data, Inc. | 2004-03-08 |
| ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (K031044) | Clinical Data, Inc. | 2003-07-15 |
| URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096) | Bayer Diagnostics Corp. | 2003-03-18 |
| WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (K023550) | Wiener Laboratories Saic | 2002-12-09 |
| JAS URIC ACID LIQUID REAGENT (K012038) | Jas Diagnostics, Inc. | 2001-08-21 |
| WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 (K010421) | Wiener Laboratories Saic | 2001-04-13 |
| WAKO L-TYPE UA F TEST (K993469) | Wako Chemicals USA, Inc. | 1999-11-09 |
| URIC ACID, MODEL UA112-01 (K991247) | A.P. Total Care, Inc. | 1999-05-25 |
| CARESIDE URIC ACID (K981604) | Careside, Inc. | 1998-06-25 |
| SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919) | Beckman Instruments, Inc. | 1997-05-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Cat recall (Z-0912-2010) | Pointe Scientific, Inc. | 2010-03-02 |
| Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; recall (Z-0913-2010) | Pointe Scientific, Inc. | 2010-03-02 |