The following data is part of a premarket notification filed by Parasitic Disease Consultants with the FDA for Polychaco Indirect Hemagglutination.
Device ID | K830870 |
510k Number | K830870 |
Device Name: | POLYCHACO INDIRECT HEMAGGLUTINATION |
Classification | Antigens, Iha, Toxoplasma Gondii |
Applicant | PARASITIC DISEASE CONSULTANTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GMM |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-18 |
Decision Date | 1983-08-12 |