510(k) K922762
- Device
- ROCHE REAGENT FOR URIC ACID--MODIFICATION
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K922762
- Product code
- KNK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-09
- Date received
- 1992-05-19
- Regulation
- 862.1775
- Classification name
- Acid, Uric, Uricase (colorimetric)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- 1080 Us Hwy. 202 Branchburg NJ US 08876 08876
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 3003795116
- 2030861
- 3038206980
- 1181121
- 9680746
- 2050012
- 3007301207
- 3005333358
- 3003741796
- 9610529
- 2432235
- 1319809
- 3012963943
- 2250051
- 1832216
- 8040374
- 3002809144
- 1036362
- 3043127699
- 2517506
- 2247288
- 3007662974
- 3021010433
- 1827821
- 3021186226
- 3011989923
- 3004493545
- 3030648160
- 2939693
- 3003593973
- 3008987086
- 3016438761
- 3002642396
- 2050010
- 3016859940
- 2085064
- 1616487
- 3014325803
- 9610126
- 1220972
- 1319681
- 3021841051
- 3000308930
- 3006716639
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102568 | URIC ACID MODEL 3P39 | Abbott Laboratories | 2011-05-06 |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Olympus America, Inc. | 2007-04-06 |
| K040467 | VITALAB URIC ACID REAGENT | Clinical Data, Inc. | 2004-03-08 |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Clinical Data, Inc. | 2003-07-15 |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2003-03-18 |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-08-21 |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 | Wiener Laboratories Saic | 2001-04-13 |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | 1999-11-09 |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K981604 | CARESIDE URIC ACID | Careside, Inc. | 1998-06-25 |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | Beckman Instruments, Inc. | 1997-05-21 |
| K970867 | URIC ACID REAGENT | Derma Media Lab., Inc. | 1997-04-21 |
| K971133 | URIC, UA, OR URIC ACID | Carolina Liquid Chemistries Corp. | 1997-04-14 |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-03-11 |
Legacy Summary#
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FDA Review#
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