Refrigerator, Freezer, Blood Storage
FDA product code KSE · Class II (moderate risk) · 21 CFR 864.9700 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884436 | Modified Low-Temp. Freezer Model HLT-80LS-85KSE · Traditional | Harris Mfg. Co. | 12/02/1988SE |
| K813327 | Sepcor Temperature MonitorKSE · Traditional | Separation Science Corp. | 12/31/1981SE |
| K802319 | Hemotemp TMKSE · Traditional | Marion Laboratories, Inc. | 10/10/1980SE |
| K800667 | Monitemp Blood Pack Temp. MonitorKSE · Traditional | Liquid Crystal Products, Inc. | 04/16/1980SE |