The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Directigen 1-2-3 Pregnancy Controls.
| Device ID | K911664 |
| 510k Number | K911664 |
| Device Name: | DIRECTIGEN 1-2-3 PREGNANCY CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Craig Watson |
| Correspondent | Craig Watson QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-05-31 |