The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit 2000 Gentamicin Plus Assay.
| Device ID | K010984 |
| 510k Number | K010984 |
| Device Name: | EMIT 2000 GENTAMICIN PLUS ASSAY |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023316 | K010984 | 000 |