CIBA CORNING MODEL 644
FDA 510(k) clearance K875098 · decided 1988-03-03
Clearance details
- K-number
- K875098
- Device name
- CIBA CORNING MODEL 644
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-10
- Decision date
- 1988-03-03
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JXR
- Device class
- 1
- Regulation number
- 862.2850
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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| MODEL 3030 ATOMIC ABSORPTION SPECTRO- (K820320) | The Perkin-Elmer Corp. | 1982-03-01 |
| ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB (K810536) | The Perkin-Elmer Corp. | 1981-03-17 |
| SPECTROPHATOMETER MODELS 2280 & 2380AA (K792557) | The Perkin-Elmer Corp. | 1980-01-16 |
| ATOMIC SPECTROSCOPY SYSTEM (K792146) | The Perkin-Elmer Corp. | 1979-11-30 |
| MODEL MHS-20, ATOMIC ABSORPTION ACCESS (K791074) | The Perkin-Elmer Corp. | 1979-08-22 |
| MODEL 4000, SPECTROPHOTOMETER (K790795) | The Perkin-Elmer Corp. | 1979-07-24 |
| SPECTROPHOTOMETER SYSTEM, MODEL AA-475 (K790781) | Varian Assoc., Inc. | 1979-05-03 |
| ATOMIC ABSORPTION SPECTROPHOTOMETER, (K790780) | Varian Assoc., Inc. | 1979-05-03 |
Recalls involving this device
No recalls on record reference this clearance.