Submission Details
| 510(k) Number | K062787 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2006 |
| Decision Date | December 29, 2006 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01
Dec 2006
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K062787 is an FDA 510(k) clearance for the ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on December 29, 2006, 102 days after receiving the submission on September 18, 2006. 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
K123713 · Immco Diagnostics, Inc.
· Oct 2013
More from Phadia US, Inc.
View all
K141375
· DBM · Feb 2015
K140225
· MOB · Oct 2014
K132631
· LKP · Aug 2014
K131821
· MID · Dec 2013
K122197
· DHB · Aug 2013