The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Serodot Toxoplasma Igg Test Kit.
Device ID | K875363 |
510k Number | K875363 |
Device Name: | SERODOT 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 |
Correspondent | El-badry 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 | 1987-12-31 |
Decision Date | 1988-04-21 |