The following data is part of a premarket notification filed by Separation Science Corp. with the FDA for Sepcor Unit Collection Monitor.
| Device ID | K820712 |
| 510k Number | K820712 |
| Device Name: | SEPCOR UNIT COLLECTION MONITOR |
| Classification | Device, Blood Mixing And Blood Weighing |
| Applicant | SEPARATION SCIENCE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KSQ |
| CFR Regulation Number | 864.9195 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-15 |
| Decision Date | 1982-05-07 |