The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit Ii Plus Benzodiazepine Assay, Model 0sr9f229.
| Device ID | K011306 |
| 510k Number | K011306 |
| Device Name: | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Contact | Cynthia Arredono |
| Correspondent | Cynthia Arredono SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023392 | K011306 | 000 |