Submission Details
| 510(k) Number | K123713 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 04, 2012 |
| Decision Date | October 25, 2013 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
Oct 2013
Decision
325d
Days
Class 2
Risk
About This 510(k) Submission
K123713 is an FDA 510(k) clearance for the IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 25, 2013, 325 days after receiving the submission on December 4, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
Manufacturer
Similar Devices — MVM Autoantibodies, Endomysial(tissue Transglutaminase)
All 39
K200230 · Inova Diagnostics, Inc.
· Aug 2021
K193604 · Inova Diagnostics, Inc.
· Jun 2021
K181871 · Phadia AB
· Mar 2019
K183313 · Euroimmun Us, Inc.
· Feb 2019
K140691 · Sqi Diagnostics Systems, Inc.
· Nov 2014
K130053 · Bio-Rad Laboratories, Inc.
· Sep 2013
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