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 |