IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT— 510(k) K964344
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K964344 for IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT, Substantially Equivalent on 1997-05-30. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Recent devices under product code MST
view all- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
- K113377 — GLIADIN IGA AND GLIADIN LGA
- K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
- K111414 — QUANTA FLASH (TM) DGP SCREEN
More clearances from Immco Diagnostics, Inc.
view all- K172745 — ImmuGlo HEp-2 Elite IFA
- K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA
- K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- K151559 — ImmuLisa Enhanced Centromere Antibody ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.