The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit 2000 Carbamazepine Assay, Model Osr4f229.
| Device ID | K010814 |
| 510k Number | K010814 |
| Device Name: | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-19 |
| Decision Date | 2001-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023231 | K010814 | 000 |