510(k) K073072
- Device
- DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K073072
- Product code
- JHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-21
- Date received
- 2007-10-31
- Regulation
- 862.1475
- Classification name
- Colorimetric Method, Lipoproteins
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA A JURGA
- Address
- Glasgow Business Community; Bldg. 500 Mail Box 514 P.O. Box 6101, Newark DE US 19714 19714
FDA Registration Numbers#
- 2517506
- 3010825766
- 1181055
- 3014325803
Source Documents#
Other 510(k) Records For Product Code JHM #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary