The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Dau Multi-drug Calibrators.
| Device ID | K980853 |
| 510k Number | K980853 |
| Device Name: | CEDIA DAU MULTI-DRUG CALIBRATORS |
| Classification | Calibrators, Drug Mixture |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-04-21 |
| Summary: | summary |