QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS— 510(k) K113863
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K113863 for QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS, Substantially Equivalent on 2012-09-20. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Inova 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
- San Diego, CA, 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
- K111414 — QUANTA FLASH (TM) DGP SCREEN
- K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
More clearances from Inova Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.