The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Dau Eddp Assay.
| Device ID | K980746 |
| 510k Number | K980746 |
| Device Name: | CEDIA DAU EDDP ASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Julie Smith |
| Correspondent | Julie Smith BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-26 |
| Decision Date | 1998-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012530 | K980746 | 000 |
| 00884883004320 | K980746 | 000 |
| 00884883004252 | K980746 | 000 |
| 00884883004214 | K980746 | 000 |