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 |
00380740011215 | K052826 | 000 |