The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Zonisamide Reagents, Calibrators And Controls.
| Device ID | K051211 |
| 510k Number | K051211 |
| Device Name: | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS |
| Classification | Immunoassay, Anti-seizure Drug |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Product Code | NWM |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-11 |
| Decision Date | 2005-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012714 | K051211 | 000 |
| 00884883011236 | K051211 | 000 |
| 00884883011229 | K051211 | 000 |
| 00884883011199 | K051211 | 000 |