The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Directigen1-2-3 Bhcg Pregnancy Test.
| Device ID | K890615 |
| 510k Number | K890615 |
| Device Name: | DIRECTIGEN1-2-3 BHCG PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR COURT 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 | 1989-02-07 |
| Decision Date | 1989-04-18 |