Dimension Vista HDLC Flex Reagent Cartridge
FDA 510(k) K081300 · Siemens Healthcare Diagnostics
510(k) numberK081300
Submission
- Device name
- Dimension Vista HDLC Flex Reagent Cartridge
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- May 8, 2008
- Decision date
- July 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHM – Colorimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | Abaxis, Inc. | 04/24/2012SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | Dade Behring, Inc. | 02/21/2008SE |
| K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48AJHM · Traditional | Dade Behring, Inc. | 10/30/2003SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | Jas Diagnostics, Inc. | 09/30/2002SE |
| K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent CartridgeJHM · Traditional | Dade Behring, Inc. | 01/11/1999SE |
| K902935 | Roche Cobas Ready HDL Cholesterol ReagentJHM · Traditional | Roche Diagnostic Systems, Inc. | 09/27/1990SE |
| K841056 | HDL Precipitant Reagent SetJHM · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K780173 | Lypoprotein Cholesterol Test KitJHM · Traditional | Environmental Chemical Specialties | 05/03/1978SE |
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Questions and answers
When was Dimension Vista HDLC Flex Reagent Cartridge cleared by the FDA?
Dimension Vista HDLC Flex Reagent Cartridge (K081300) received a 510(k) decision of Substantially Equivalent on July 2, 2008, 55 days after the submission was received.
What is the product code of K081300?
The FDA product code is JHM – Colorimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.