The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Directigen 1-2-3 Infectious Mononucleosis Test.
| Device ID | K893737 |
| 510k Number | K893737 |
| Device Name: | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST |
| Classification | System, Test, Infectious Mononucleosis |
| 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 | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-17 |
| Decision Date | 1989-06-16 |