DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE— 510(k) K081300
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K081300 for DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2008-07-02. Applicant: Siemens Healthcare Diagnostics. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JHM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
Recent devices under product code JHM
view all- K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM
- K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- K022519 — LDL CHOLESTEROL (AUTOMATED)
- K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
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Recalls naming K081300
K-number listed on FDA's recall record- Z-0089-2023 — Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
- Z-1188-2021 — Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.