The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Modified Ddi Serocard Toxoplasma Igg Test Kit.
Device ID | K884249 |
510k Number | K884249 |
Device Name: | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Contact | El-badry, Phd |
Correspondent | El-badry, Phd DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
Product Code | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-11 |
Decision Date | 1989-04-10 |