The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Emit 2000 Gentamicin Assay And Calibrators.
Device ID | K962519 |
510k Number | K962519 |
Device Name: | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS |
Classification | Enzyme Immunoassay, Gentamicin |
Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Contact | Paul L Rogers |
Correspondent | Paul L Rogers BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Product Code | LCD |
CFR Regulation Number | 862.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-27 |
Decision Date | 1996-09-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414561943 | K962519 | 000 |
00842768001093 | K962519 | 000 |
00842768001086 | K962519 | 000 |