The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard Hcg One Step (i-s) Test Kit.
| Device ID | K911826 |
| 510k Number | K911826 |
| Device Name: | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT |
| 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 | 1991-04-24 |
| Decision Date | 1991-07-19 |