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 |