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 |