The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Multigent Gentamicin.
| Device ID | K060709 |
| 510k Number | K060709 |
| Device Name: | MULTIGENT GENTAMICIN |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Contact | Earl E Knight |
| Correspondent | Earl E Knight SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2006-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740135522 | K060709 | 000 |
| 00380740000301 | K060709 | 000 |