COBAS 6000 SERIES SYSTEM
FDA 510(k) clearance K060373 · decided 2006-03-13
Clearance details
- K-number
- K060373
- Device name
- COBAS 6000 SERIES SYSTEM
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2006-02-13
- Decision date
- 2006-03-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - recall (Z-0378-2018) | Roche Diagnostics Corporation | 2018-01-16 |
| cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No recall (Z-1791-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 0 recall (Z-1792-2014) | Roche Diagnostics Operations, Inc. | 2014-06-14 |
| Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc recall (Z-0542-2009) | Roche Diagnostics Corp. | 2009-01-06 |
| Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnosti recall (Z-0576-2008) | Roche Diagnostics Corp. | 2008-03-04 |
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|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
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| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
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