Unit, Drying
FDA product code JRJ · Class I (low risk) · 21 CFR 862.2050 · Clinical Chemistry
1510(k) clearances
0PMA approvals
3recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K791077 | Beckman Electrophoresis Oven/IncubatorJRJ · Traditional | Beckman Instruments, Inc. | 07/24/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3034-2017 Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009…Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Cenorin, LLC | 06/07/2017Terminated |
| Z-3033-2017 Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330…Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Cenorin, LLC | 06/07/2017Terminated |
| Z-3032-2017 Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135…Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Cenorin, LLC | 06/07/2017Terminated |