The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Ip Specific E.
| Device ID | K821094 |
| 510k Number | K821094 |
| Device Name: | IP SPECIFIC E |
| Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC REAGENT TECH. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DGO |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-19 |
| Decision Date | 1982-05-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IP SPECIFIC E 73412283 1308496 Dead/Cancelled |
DRT, Inc. 1983-02-04 |