The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Emit Ii Opiates 300/2000 Assay.
| Device ID | K971596 |
| 510k Number | K971596 |
| Device Name: | EMIT II OPIATES 300/2000 ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | David Kolesar |
| Correspondent | David Kolesar BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596105 | K971596 | 000 |
| 00630414568799 | K971596 | 000 |
| 00842768014338 | K971596 | 000 |
| 00842768001826 | K971596 | 000 |
| 00842768001819 | K971596 | 000 |