The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Quinidine. Qms Quinidine Calibrators.
| Device ID | K052826 |
| 510k Number | K052826 |
| Device Name: | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS |
| Classification | Enzyme Immunoassay, Quinidine |
| 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 | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-05 |
| Decision Date | 2005-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011222 | K052826 | 000 |
| 00884883006003 | K052826 | 000 |
| 00884883005990 | K052826 | 000 |