Atlas FDA

ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA

FDA 510(k) clearance K143736 · decided 2015-09-23

Clearance details

K-number
K143736
Device name
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
Applicant
Immco Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2014-12-30
Decision date
2015-09-23
Days to decision
267 days
Clearance type
Traditional
Product code
DHR
Device class
2
Regulation number
866.5775
Medical specialty
Immunology
Advisory committee
Immunology
Location
Clarence, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.