CENTRIA SYSTEM
FDA 510(k) clearance K790550 · decided 1979-05-07
Clearance details
- K-number
- K790550
- Device name
- CENTRIA SYSTEM
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-03-20
- Decision date
- 1979-05-07
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JJG
- Device class
- 1
- Regulation number
- 862.2140
- 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 |
|---|---|---|
| AG CHEMISTRY ANALYZER SYSTEM (K972409) | Landmark Scientific, Inc. | 1997-08-28 |
| PICCOLO(TM) (K942782) | Abaxis, Inc. | 1995-03-13 |
| EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (K934592) | Abaxis, Inc. | 1994-04-06 |
| OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942) | Olympus Corp. | 1992-06-10 |
| COBAS ALPHA (K910222) | Roche Diagnostic Systems, Inc. | 1991-02-27 |
| BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (K903626) | Beckman Instruments, Inc. | 1990-10-15 |
| COBAS FARA II CENTRIFUGAL ANALYZER (K893854) | Roche Diagnostic Systems, Inc. | 1989-08-03 |
| COBAS FARA CENTRIFUGAL ANALYZER (K893641) | Roche Diagnostic Systems, Inc. | 1989-07-20 |
| TECHNICON DAX(TM) SYSTEM (K885203) | Technicon Instruments Corp. | 1989-03-28 |
| IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973) | Instrumentation Laboratory CO | 1987-06-11 |
| BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838) | Beckman Instruments, Inc. | 1987-05-26 |
| ANALYST PHYSICIAN'S OFFICE PROFILER (K854523) | E.I. Dupont DE Nemours & Co., Inc. | 1986-01-08 |
Recalls involving this device
No recalls on record reference this clearance.