The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace(tm) Cedia(r) Phenytoin Assay.
| Device ID | K944085 |
| 510k Number | K944085 |
| Device Name: | ACE(TM) CEDIA(R) PHENYTOIN ASSAY |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Mark A Spain |
| Correspondent | Mark A Spain SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1994-12-28 |