510(k) K875098
- Device
- CIBA CORNING MODEL 644
- Applicant
- CIBA CORNING DIAGNOSTICS CORP.
- 510(k) number
- K875098
- Product code
- JXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-03
- Date received
- 1987-12-10
- Regulation
- 862.2850
- Classification name
- Atomic Absorption Spectrophotometer, General Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- William J Pignato
- Address
- 333 Coney St. East Walpole MA US 02032 02032
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900828 | PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. | The Perkin-Elmer Corp. | 1990-04-09 |
| K842752 | ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT | The Perkin-Elmer Corp. | 1984-08-22 |
| K842496 | ICP/6500 INDUCTIVELY-COUPLED PLASMA- | The Perkin-Elmer Corp. | 1984-08-10 |
| K830799 | INDUCTIVELY-COUPLED PLASMA SPECTROMETER | The Perkin-Elmer Corp. | 1983-04-12 |
| K820320 | MODEL 3030 ATOMIC ABSORPTION SPECTRO- | The Perkin-Elmer Corp. | 1982-03-01 |
| K810536 | ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB | The Perkin-Elmer Corp. | 1981-03-17 |
| K792557 | SPECTROPHATOMETER MODELS 2280 & 2380AA | The Perkin-Elmer Corp. | 1980-01-16 |
| K792146 | ATOMIC SPECTROSCOPY SYSTEM | The Perkin-Elmer Corp. | 1979-11-30 |
| K791074 | MODEL MHS-20, ATOMIC ABSORPTION ACCESS | The Perkin-Elmer Corp. | 1979-08-22 |
| K790795 | MODEL 4000, SPECTROPHOTOMETER | The Perkin-Elmer Corp. | 1979-07-24 |
| K790781 | SPECTROPHOTOMETER SYSTEM, MODEL AA-475 | Varian Assoc., Inc. | 1979-05-03 |
| K790780 | ATOMIC ABSORPTION SPECTROPHOTOMETER, | Varian Assoc., Inc. | 1979-05-03 |
| K790111 | ATOMIZER, FURNACE MODEL HGA-400 | The Perkin-Elmer Corp. | 1979-04-04 |
| K790117 | AUTOSAMPLER, MODEL AS-40 | The Perkin-Elmer Corp. | 1979-03-19 |
| K780522 | SPECTROPHOTOMETERS, ATOMIC ABSORPTION | Instrumentation Laboratory CO | 1978-05-12 |
Legacy Summary#
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FDA Review#
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