The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Lh Gen Iii Self-test/conceive.
| Device ID | K920160 |
| 510k Number | K920160 |
| Device Name: | LH GEN III SELF-TEST/CONCEIVE |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | John D Tamerius |
| Correspondent | John D Tamerius QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1992-03-11 |