PRO-STEP HCG
Visual, Pregnancy Hcg, Prescription Use
DISEASE DETECTION INTERNATIONAL, INC.
The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Pro-step Hcg.
Pre-market Notification Details
| Device ID | K925125 |
| 510k Number | K925125 |
| Device Name: | PRO-STEP 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 | 1992-10-13 |
| Decision Date | 1993-01-13 |
Trademark Results [PRO-STEP HCG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-STEP HCG 74322716 not registered Dead/Abandoned |
Disease Detection International 1992-10-15 |
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