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 |