The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Phenytoin Ii Assay.
| Device ID | K963840 |
| 510k Number | K963840 |
| Device Name: | CEDIA PHENYTOIN II ASSAY |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord, CA 94524 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-24 |
| Decision Date | 1996-11-20 |
| Summary: | summary |