The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Cedia Phenobarbital Assay.
| Device ID | K942501 |
| 510k Number | K942501 |
| Device Name: | ACE CEDIA PHENOBARBITAL ASSAY |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Mark A Spain, Ph.d. |
| Correspondent | Mark A Spain, Ph.d. SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1994-10-06 |