Submission Details
| 510(k) Number | K052819 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2005 |
| Decision Date | December 23, 2005 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
Dec 2005
Decision
80d
Days
Class 2
Risk
About This 510(k) Submission
K052819 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 23, 2005, 80 days after receiving the submission on October 4, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.
Device Classification
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5130 |
Manufacturer
Similar Devices — DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
All 29
K123256 · The Binding Site Group , Ltd.
· Jul 2013
K063610 · Dade Behring, Inc.
· Jan 2007
K053072 · Dade Behring, Inc.
· Mar 2006
K050596 · Biokit, S.A.
· May 2005
K031857 · Bayer Diagnostics Corp.
· Sep 2003
K011663 · The Binding Site, Ltd.
· Jul 2001
More from Ortho-Clinical Diagnostics,...
View all
K252393
· MMI · Oct 2025
DEN210038
· QVP · May 2023
DEN210040
· QVP · May 2023
K210858
· DLZ · Aug 2021
K191316
· CIX · Jun 2019