The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace(tm) Cedia(r) Ferritin Assay.
| Device ID | K950393 |
| 510k Number | K950393 |
| Device Name: | ACE(TM) CEDIA(R) FERRITIN ASSAY |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| 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 | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-05-16 |