The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Factor Xii Deficient Plasma.
| Device ID | K883688 |
| 510k Number | K883688 |
| Device Name: | ORTHO FACTOR XII DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patricia Bonness |
| Correspondent | Patricia Bonness ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-11-01 |