The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Assayed Reference Plasma-normal/ Plasma-abnormal.
| Device ID | K940209 |
| 510k Number | K940209 |
| Device Name: | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL |
| Classification | Plasma, Coagulation Control |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patrick A Roche |
| Correspondent | Patrick A Roche ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1995-05-11 |