The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Pro-step Lh Ovulation Prediction Test.
| Device ID | K943252 |
| 510k Number | K943252 |
| Device Name: | PRO-STEP LH OVULATION PREDICTION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
| Contact | Siegfried Krutzik |
| Correspondent | Siegfried Krutzik DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-10-25 |