Product code JHM
- Device name
- Colorimetric Method, Lipoproteins
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1475
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2012-04-24 |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2008-07-02 |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Dade Behring, Inc. | 2008-02-21 |
| K032798 | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A | Dade Behring, Inc. | 2003-10-30 |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Jas Diagnostics, Inc. | 2002-09-30 |
| K983849 | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-01-11 |
| K902935 | ROCHE COBAS READY HDL CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | 1990-09-27 |
| K841056 | HDL PRECIPITANT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | Environmental Chemical Specialties | 1978-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971674861140 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674868415 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674867760 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861485 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861478 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861461 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861454 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861447 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861430 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861423 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861416 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861409 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861393 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861386 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861195 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861188 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861171 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861164 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861157 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 06971674861133 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-20 |
| 00842768020438 | Dimension Vista® Flex® reagent cartridge HDLC | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768022029 | Dimension® Flex® reagent cartridge AHDL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00817274022597 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2017-08-21 |
| 00817274021880 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2016-09-12 |