The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Vancomycin.
Device ID | K050419 |
510k Number | K050419 |
Device Name: | QMS VANCOMYCIN |
Classification | Radioimmunoassay, Vancomycin |
Applicant | SERADYN INC. 7998 GEORGETOWN RD. Indianapolis, IN 46268 |
Contact | Jack Rogers |
Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. Indianapolis, IN 46268 |
Product Code | LEH |
CFR Regulation Number | 862.3950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-18 |
Decision Date | 2005-04-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00380740135348 | K050419 | 000 |
00380740009847 | K050419 | 000 |
00884883012837 | K050419 | 000 |
00884883011182 | K050419 | 000 |