The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho B-hcg Slide Test For Pregnancy.
| Device ID | K833137 |
| 510k Number | K833137 |
| Device Name: | ORTHO B-HCG SLIDE TEST FOR PREGNANCY |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-14 |
| Decision Date | 1984-01-18 |