The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Clinical Chemistry System.
| Device ID | K941489 |
| 510k Number | K941489 |
| Device Name: | ACE CLINICAL CHEMISTRY SYSTEM |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-07-18 |