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 |