The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit 2000 Digoxin Assay, Model Osr4h229.
| Device ID | K011920 |
| 510k Number | K011920 |
| Device Name: | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SYVA CO., DADE BEHRING, INC. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Contact | Susan L Collins |
| Correspondent | Susan L Collins SYVA CO., DADE BEHRING, INC. 20400 MARIANI AVE. Cupertino, CA 95014 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023255 | K011920 | 000 |