MODEL 4000, SPECTROPHOTOMETER
Device Facts
| Record ID | K790795 |
|---|---|
| Device Name | MODEL 4000, SPECTROPHOTOMETER |
| Applicant | The Perkin-Elmer Corp. |
| Product Code | JXR · Clinical Chemistry |
| Decision Date | Jul 24, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2850 |
| Device Class | Class 1 |
Regulatory Classification
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.
