The following data is part of a premarket notification filed by Panmed, Inc. with the FDA for Sickle-check.
| Device ID | K820642 |
| 510k Number | K820642 |
| Device Name: | SICKLE-CHECK |
| Classification | Test, Sickle Cell |
| Applicant | PANMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SICKLE-CHECK 73358040 1254191 Dead/Cancelled |
Diagnostic Technology, Inc. 1982-04-05 |