MODEL 654 ANALYZER
FDA 510(k) clearance K921403 · decided 1992-07-30
Clearance details
- K-number
- K921403
- Device name
- MODEL 654 ANALYZER
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-24
- Decision date
- 1992-07-30
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- JIH
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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| TDX(R) LITES(TM) LITHIUM (K894328) | Abbott Laboratories | 1989-11-13 |
| POTASSIUM DILUENT (K830636) | Shaban Mfg. Co. | 1983-04-05 |
| LITHIUM DILUENT (1500 MM/E) (K800039) | Gilford Diagnostics | 1980-01-21 |
| FLAME PHOTOMETER MODEL 460 (K771303) | Corning Medical & Scientific | 1977-08-22 |
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Recalls involving this device
No recalls on record reference this clearance.