The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Quik-sep(r) Igm Rprotein G Affinity Method.
| Device ID | K901453 |
| 510k Number | K901453 |
| Device Name: | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Loren F Hazelwood |
| Correspondent | Loren F Hazelwood ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-27 |
| Decision Date | 1990-04-12 |