The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Chagas' Igg Elisa Test.
Device ID | K911233 |
510k Number | K911233 |
Device Name: | CHAGAS' IGG ELISA TEST |
Classification | Enzyme Linked Immunosorbent Assay, T. Cruzi |
Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
Contact | Fred W Rachford |
Correspondent | Fred W Rachford GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
Product Code | MIU |
CFR Regulation Number | 866.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-20 |
Decision Date | 1992-05-04 |