The following data is part of a premarket notification filed by Rapid Diagnostics, Inc. with the FDA for Rapidhcg Pregnancy Test.
| Device ID | K981770 |
| 510k Number | K981770 |
| Device Name: | RAPIDHCG PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | RAPID DIAGNOSTICS, INC. 837 COWAN RD. Burlingame, CA 94010 -1204 |
| Contact | Charles Yu |
| Correspondent | Charles Yu RAPID DIAGNOSTICS, INC. 837 COWAN RD. Burlingame, CA 94010 -1204 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-06-05 |