The following data is part of a premarket notification filed by Vanguard Biomedical Corp. with the FDA for Miniclinic Ovulation Prediction Test.
| Device ID | K910351 |
| 510k Number | K910351 |
| Device Name: | MINICLINIC OVULATION PREDICTION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego, CA 92111 |
| Contact | John Chiu |
| Correspondent | John Chiu VANGUARD BIOMEDICAL CORP. 7822 CONVOY COURT San Diego, CA 92111 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-03-21 |