510(k) K071211
- Device
- COBAS C 111 ANALYZER
- Applicant
- Roche Diagnostics
- 510(k) number
- K071211
- Product code
- CIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-30
- Date received
- 2007-05-01
- Regulation
- 862.1100
- Classification name
- Nadh Oxidation/nad Reduction, Ast/sgot
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CORINA HARPER
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 8040374
- 8020316
- 3006716639
- 2030861
- 2517506
- 3016438761
- 1000403749
- 3005333358
- 3006198300
- 3013660430
- 3004493545
- 3011989923
- 9680746
- 3000308930
- 2085064
- 1616487
- 3002809144
- 3010825766
- 3018771894
- 3002642396
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 9610126
- 3003795116
- 1319809
- 3004438098
- 1181121
- 2939693
- 3012963943
- 1832216
- 3021841051
- 3005146313
- 1827821
- 2250051
- 2247288
- 1717966
- 2050012
- 1063851
- 3009473156
- 9610529
- 3014325803
- 2050010
- 8030478
- 3007662974
- 3014607865
- 3003741796
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code CIT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | Seppim S.A.S. | 2010-09-20 |
| K080485 | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | Diasys Diagnostics Systems GmbH | 2008-12-04 |
| K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | 2008-03-19 |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-03 |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2006-08-08 |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | 2001-12-21 |
| K013145 | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. | Wiener Laboratories Saic | 2001-11-27 |
| K010488 | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | 2001-04-09 |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | 2000-06-28 |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | 1999-12-16 |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | 1999-11-09 |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | Sigma Diagnostics, Inc. | 1999-09-28 |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | 1999-06-30 |
| K990009 | CARESIDE AST | Careside, Inc. | 1999-03-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary