The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Tobramycin.
| Device ID | K060998 |
| 510k Number | K060998 |
| Device Name: | QMS TOBRAMYCIN |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | SERADYN, INC. 7998 GEORGETOWN RD., STE. 1000 Indianapolis, IN 46268 -5260 |
| Contact | Earl E Knight Iii |
| Correspondent | Earl E Knight Iii SERADYN, INC. 7998 GEORGETOWN RD., STE. 1000 Indianapolis, IN 46268 -5260 |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-11 |
| Decision Date | 2006-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740154141 | K060998 | 000 |
| 00380740013127 | K060998 | 000 |
| 00884883012691 | K060998 | 000 |