JXR · Atomic Absorption Spectrophotometer, General Use
Clinical Chemistry · 21 CFR 862.2850 · Class 1
Overview
| Product Code | JXR |
|---|---|
| Device Name | Atomic Absorption Spectrophotometer, General Use |
| Regulation | 21 CFR 862.2850 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and metals (e.g., lead and mercury) in human specimens. The metal elements are identified according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900828 | PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. | The Perkin-Elmer Corp. | Apr 9, 1990 | SESE |
| K875098 | CIBA CORNING MODEL 644 | Ciba Corning Diagnostics Corp. | Mar 3, 1988 | SESE |
| K842752 | ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT | The Perkin-Elmer Corp. | Aug 22, 1984 | SESE |
| K842496 | ICP/6500 INDUCTIVELY-COUPLED PLASMA- | The Perkin-Elmer Corp. | Aug 10, 1984 | SESE |
| K830799 | INDUCTIVELY-COUPLED PLASMA SPECTROMETER | The Perkin-Elmer Corp. | Apr 12, 1983 | SESE |
| K820320 | MODEL 3030 ATOMIC ABSORPTION SPECTRO- | The Perkin-Elmer Corp. | Mar 1, 1982 | SESE |
| K810536 | ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB | The Perkin-Elmer Corp. | Mar 17, 1981 | SESE |
| K792557 | SPECTROPHATOMETER MODELS 2280 & 2380AA | The Perkin-Elmer Corp. | Jan 16, 1980 | SESE |
| K792146 | ATOMIC SPECTROSCOPY SYSTEM | The Perkin-Elmer Corp. | Nov 30, 1979 | SESE |
| K791074 | MODEL MHS-20, ATOMIC ABSORPTION ACCESS | The Perkin-Elmer Corp. | Aug 22, 1979 | SESE |
| K790795 | MODEL 4000, SPECTROPHOTOMETER | The Perkin-Elmer Corp. | Jul 24, 1979 | SESE |
| K790781 | SPECTROPHOTOMETER SYSTEM, MODEL AA-475 | Varian Assoc., Inc. | May 3, 1979 | SESE |
| K790780 | ATOMIC ABSORPTION SPECTROPHOTOMETER, | Varian Assoc., Inc. | May 3, 1979 | SESE |
| K790111 | ATOMIZER, FURNACE MODEL HGA-400 | The Perkin-Elmer Corp. | Apr 4, 1979 | SESE |
| K790117 | AUTOSAMPLER, MODEL AS-40 | The Perkin-Elmer Corp. | Mar 19, 1979 | SESE |
| K780522 | SPECTROPHOTOMETERS, ATOMIC ABSORPTION | Instrumentation Laboratory CO | May 12, 1978 | SESE |
| K780521 | SPECTROPHOTOMETER, ATOMIC ABSORPTION | Instrumentation Laboratory CO | May 12, 1978 | SESE |
| K780342 | SPECTROPHOTOMETERS | The Perkin-Elmer Corp. | Apr 10, 1978 | SESE |
| K780129 | ATOMIZER, FURNACE, GRAPHITE | The Perkin-Elmer Corp. | Apr 5, 1978 | SESE |
| K780390 | SPECTROPHOTOMETER, ABSORPTION, ATOMIC | Varian Assoc., Inc. | Mar 22, 1978 | SESE |
Top Applicants
- The Perkin-Elmer Corp. — 17 clearances
- Varian Assoc., Inc. — 6 clearances
- Instrumentation Laboratory CO — 5 clearances
- Ciba Corning Diagnostics Corp. — 1 clearance
