Cuvette, Thermostated
FDA product code JRI · Class I (low risk) · 21 CFR 862.2050 · Clinical Chemistry
4510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873656 | Medatron Cuvette DiscJRI · Traditional | Medatron, Inc. | 12/14/1987SE |
| K780888 | Thermo Set Electronic Tem. ControllerJRI · Traditional | Gilford Instrument Laboratories, Inc. | 06/28/1978SE |
| K760769 | Temperature Regulated Five Cell HoldersJRI · Traditional | The Perkin-Elmer Corp. | 11/30/1976SE |
| K760197 | Accuvette IIJRI · Traditional | Coulter Electronics, Inc. | 07/19/1976SE |