The following data is part of a premarket notification filed by Separation Science Corp. with the FDA for Sepcor Temperature Monitor.
| Device ID | K813327 |
| 510k Number | K813327 |
| Device Name: | SEPCOR TEMPERATURE MONITOR |
| Classification | Refrigerator, Freezer, Blood Storage |
| Applicant | SEPARATION SCIENCE CORP. 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 | 1981-11-24 |
| Decision Date | 1981-12-31 |