The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Clinical Chemistry System.
| Device ID | K940267 |
| 510k Number | K940267 |
| Device Name: | ACE CLINICAL CHEMISTRY SYSTEM |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Mark A Spain, Ph.d. |
| Correspondent | Mark A Spain, Ph.d. SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-05-03 |