The following data is part of a premarket notification filed by Ortho Pharmaceutical Corp. with the FDA for Advance Pregnancy Test Modification.
| Device ID | K934516 |
| 510k Number | K934516 |
| Device Name: | ADVANCE PREGNANCY TEST MODIFICATION |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-17 |
| Decision Date | 1994-02-24 |