JHM · Colorimetric Method, Lipoproteins
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | JHM |
|---|---|
| Device Name | Colorimetric Method, Lipoproteins |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Abaxis, Inc. | Apr 24, 2012 | SESE |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | Jul 2, 2008 | SESE |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Dade Behring, Inc. | Feb 21, 2008 | SESE |
| K032798 | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A | Dade Behring, Inc. | Oct 30, 2003 | SESE |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Jas Diagnostics, Inc. | Sep 30, 2002 | SESE |
| K983849 | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Jan 11, 1999 | SESE |
| K902935 | ROCHE COBAS READY HDL CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | Sep 27, 1990 | SESE |
| K841056 | HDL PRECIPITANT REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | Environmental Chemical Specialties | May 3, 1978 | SESE |
Top Applicants
- Dade Behring, Inc. — 3 clearances
- Abaxis, Inc. — 1 clearance
- Environmental Chemical Specialties — 1 clearance
- Jas Diagnostics, Inc. — 1 clearance
- Medical Specialties, Inc. — 1 clearance
