The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Serocard Hsv Igg Antibody Test Kit.
Device ID | K903070 |
510k Number | K903070 |
Device Name: | SEROCARD HSV IGG ANTIBODY TEST KIT |
Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
Applicant | DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
Contact | Julie Whiteside |
Correspondent | Julie Whiteside DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
Product Code | LGC |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-12 |
Decision Date | 1990-08-09 |