The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Dau Opiate 2k Assay.
| Device ID | K962795 |
| 510k Number | K962795 |
| Device Name: | CEDIA DAU OPIATE 2K ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004337 | K962795 | 000 |
| 00884883004269 | K962795 | 000 |