The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Theophylline Assay.
| Device ID | K961462 |
| 510k Number | K961462 |
| Device Name: | CEDIA THEOPHYLLINE ASSAY |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-maddox BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1996-06-27 |
| Summary: | summary |