Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge
FDA 510(k) K983849 · Dade Behring, Inc.
510(k) numberK983849
Submission
- Device name
- Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 30, 1998
- Decision date
- January 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
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| K081300 | Dimension Vista HDLC Flex Reagent CartridgeJHM · Special | Siemens Healthcare Diagnostics | 07/02/2008SE |
| 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 |
| 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 Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge cleared by the FDA?
Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge (K983849) received a 510(k) decision of Substantially Equivalent on January 11, 1999, 73 days after the submission was received.
What is the product code of K983849?
The FDA product code is JHM – Colorimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.