The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Pro-step Pt Hcg.
Device ID | K925303 |
510k Number | K925303 |
Device Name: | PRO-STEP PT HCG |
Classification | Visual, Pregnancy Hcg, Prescription Use |
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 | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-21 |
Decision Date | 1993-06-15 |