The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Amikacin Reagents.
| Device ID | K052815 |
| 510k Number | K052815 |
| Device Name: | QMS AMIKACIN REAGENTS |
| Classification | Radioimmunoassay, Amikacin |
| 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 | KLQ |
| CFR Regulation Number | 862.3035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2005-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740154103 | K052815 | 000 |
| 00380740011277 | K052815 | 000 |
| 00884883012660 | K052815 | 000 |
| 00884883005983 | K052815 | 000 |