The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Carbamazepine Reagent/aed Calibrators.
| Device ID | K973535 |
| 510k Number | K973535 |
| Device Name: | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Steven Dalessio |
| Correspondent | Steven Dalessio SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-10-20 |
| Summary: | summary |