The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Seradyn Qms Topiramate.
| Device ID | K070645 |
| 510k Number | K070645 |
| Device Name: | SERADYN QMS TOPIRAMATE |
| Classification | Immunoassay, Anti-seizure Drug |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Product Code | NWM |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-08 |
| Decision Date | 2007-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012707 | K070645 | 000 |
| 00884883011298 | K070645 | 000 |
| 00884883011250 | K070645 | 000 |
| 00884883011175 | K070645 | 000 |