The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Immunocard Strep A Test.
Device ID | K896109 |
510k Number | K896109 |
Device Name: | IMMUNOCARD STREP A TEST |
Classification | Antisera, All Groups, Streptococcus Spp. |
Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Contact | Julie Whiteside |
Correspondent | Julie Whiteside DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Product Code | GTZ |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-23 |
Decision Date | 1989-11-29 |