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 |