The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Contrast & Rapid Hcg Urine/serum Tst.
| Device ID | K952319 |
| 510k Number | K952319 |
| Device Name: | CONTRAST & RAPID HCG URINE/SERUM TST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MEDIX BIOTECH, INC. 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Paul Ladden |
| Correspondent | Paul Ladden MEDIX BIOTECH, INC. 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-06-20 |