The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Anti-toxoplasma Gondii Kit.
Device ID | K842664 |
510k Number | K842664 |
Device Name: | ANTI-TOXOPLASMA GONDII KIT |
Classification | Antigens, If, Toxoplasma Gondii |
Applicant | AMICO LAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GLZ |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-10 |
Decision Date | 1984-08-28 |