The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Bestest(tm) Hcg-urine, Cat# B1h0100.
| Device ID | K924259 |
| 510k Number | K924259 |
| Device Name: | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | John Chen |
| Correspondent | John Chen MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1992-11-25 |