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 |