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 |