OMNI C ANALYZER
FDA 510(k) clearance K013373 · decided 2001-11-02
Clearance details
- K-number
- K013373
- Device name
- OMNI C ANALYZER
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-11
- Decision date
- 2001-11-02
- Days to decision
- 22 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
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) | Roche Diagnostics | 2026-02-12 |
| ABL90 FLEX PLUS System (K241037) | Radiometer Medicals Aps | 2025-01-14 |
| EasyStat 300 (K220396) | Medica Corporation | 2023-09-26 |
| ISE Electrodes (K230890) | Randox Laboratories, Ltd. | 2023-09-08 |
| SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544) | Diamond Diagnostics, Inc. | 2020-10-01 |
| FLEXLAB 3.6, ACCELERATOR A3600 (K121012) | Inpeco S.P.A. | 2012-08-31 |
| SMARTLYTE ELECTROLYTE ANALYZER (K121040) | Diamond Diagnostics, Inc. | 2012-08-30 |
| GEM PREMIER 4000 (K112995) | Instrumentation Laboratory CO | 2012-05-03 |
| BIOLIS 12I (K110520) | Tokyo Boeki Medisys, Inc. | 2012-03-23 |
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |
| POLY-CHEM 90 ISE MODULE (K112408) | Polymedco, Inc. | 2011-11-04 |
| EASTLYTE NA/K/CA/PH (K112788) | Medica Corp. | 2011-10-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734. recall (Z-0438-03) | Roche Diagnostics Corp. | 2003-01-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |