The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Pregnancy Combo Test.
| Device ID | K984077 |
| 510k Number | K984077 |
| Device Name: | INSTANT-VIEW PREGNANCY COMBO TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-02-16 |
| Summary: | summary |