The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard Hcg Ii-s Test Kit.
Device ID | K895912 |
510k Number | K895912 |
Device Name: | IMMUNOCARD HCG II-S TEST KIT |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Contact | Siegfried Krutzik |
Correspondent | Siegfried Krutzik DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-10 |
Decision Date | 1989-12-01 |