Submission Details
| 510(k) Number | K083381 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2008 |
| Decision Date | April 15, 2009 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
Apr 2009
Decision
152d
Days
Class 2
Risk
About This 510(k) Submission
K083381 is an FDA 510(k) clearance for the EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG), a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on April 15, 2009, 152 days after receiving the submission on November 14, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
Similar Devices — LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control
All 28
K101319 · Immco Diagnostics, Inc.
· Dec 2010
K062183 · The Binding Site, Ltd.
· Nov 2006
K040811 · Pharmacia Deutschland GmbH
· May 2004
K001900 · Helix Diagnostics, Inc.
· Sep 2000
K000477 · Micro Detect, Inc.
· Mar 2000
K994424 · Diamedix Corp.
· Feb 2000
More from Euroimmun Us, Inc.
View all
K193115
· OEG · Sep 2020
K183313
· MVM · Feb 2019
K172582
· MOB · May 2018
K172244
· KTL · Apr 2018
K172252
· KTL · Apr 2018