Submission Details
| 510(k) Number | K143736 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 2014 |
| Decision Date | September 23, 2015 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
Sep 2015
Decision
267d
Days
Class 2
Risk
About This 510(k) Submission
K143736 is an FDA 510(k) clearance for the ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on September 23, 2015, 267 days after receiving the submission on December 30, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.
Device Classification
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5775 |
Manufacturer
Similar Devices — DHR System, Test, Rheumatoid Factor
All 143
K192727 · Kamiya Biomedical Company
· May 2020
K190088 · Inova Diagnostics, Inc.
· Apr 2019
K182747 · Phadia AB
· Dec 2018
K162263 · The Binding Site Group , Ltd.
· May 2017
K160070 · The Binding Site Group , Ltd.
· Dec 2016
K102673 · Phadia US, Inc.
· Sep 2011
More from Immco Diagnostics, Inc.
View all
K172745
· DHN · Jun 2018
K172078
· NYO · Mar 2018
K163133
· DBM · Aug 2017
K163177
· MST · Jul 2017
K162788
· MSV · Jun 2017