Submission Details
| 510(k) Number | K012593 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 10, 2001 |
| Decision Date | August 30, 2001 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Aug 2001
Decision
20d
Days
Class 1
Risk
About This 510(k) Submission
K012593 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 30, 2001, 20 days after receiving the submission on August 10, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.
Device Classification
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |
Manufacturer
Similar Devices — LBR Ldl & Vldl Precipitation, Hdl
All 65
K143691 · Roche Diagnostics Operations (Rdo)
· Jan 2015
K072523 · General Atomics
· Jan 2008
K050823 · Teco Diagnostics
· Jul 2005
K023784 · Hemagen Diagnostics, Inc.
· Dec 2002
K992029 · Elan Diagnostics
· Aug 1999
K992002 · Pointe Scientific, Inc.,
· Aug 1999
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