The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Hemotemp Tm.
| Device ID | K802319 |
| 510k Number | K802319 |
| Device Name: | HEMOTEMP TM |
| Classification | Refrigerator, Freezer, Blood Storage |
| Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KSE |
| CFR Regulation Number | 864.9700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-10 |