URIC ACID SYSTEM PACK TEST
FDA 510(k) clearance K812978 · decided 1981-11-06
Clearance details
- K-number
- K812978
- Device name
- URIC ACID SYSTEM PACK TEST
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-23
- Decision date
- 1981-11-06
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KNK
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |