The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Quik-sep Igm Isolation System.
| Device ID | K830606 |
| 510k Number | K830606 |
| Device Name: | QUIK-SEP IGM ISOLATION SYSTEM |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | ISOLAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-25 |
| Decision Date | 1983-03-24 |