The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Sickle-check.
Device ID | K820037 |
510k Number | K820037 |
Device Name: | SICKLE-CHECK |
Classification | Control, Hemoglobin, Abnormal |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JCM |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-07 |
Decision Date | 1982-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SICKLE-CHECK 73358040 1254191 Dead/Cancelled |
Diagnostic Technology, Inc. 1982-04-05 |