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 |