The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Cedia Cortisol Assay.
| Device ID | K943427 |
| 510k Number | K943427 |
| Device Name: | ACE CEDIA CORTISOL ASSAY |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Mark A Spain |
| Correspondent | Mark A Spain SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1994-11-28 |