The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard(tm) Hcg Ii Test Kit.
Device ID | K881709 |
510k Number | K881709 |
Device Name: | IMMUNOCARD(TM) HCG II TEST KIT |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Contact | R Krutzik |
Correspondent | R 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 | 1988-04-20 |
Decision Date | 1988-07-08 |