The following data is part of a premarket notification filed by Advantage Diagnostics Corp. with the FDA for Advantage Hcg Test (urine/serum).
| Device ID | K994227 |
| 510k Number | K994227 |
| Device Name: | ADVANTAGE HCG TEST (URINE/SERUM) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ADVANTAGE DIAGNOSTICS CORP. 2440 LEGHORN ST. Mountain View, CA 94043 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone ADVANTAGE DIAGNOSTICS CORP. 2440 LEGHORN ST. Mountain View, CA 94043 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-15 |
| Decision Date | 2000-02-03 |
| Summary: | summary |