DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K081300 · decided 2008-07-02
Clearance details
- K-number
- K081300
- Device name
- DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2008-05-08
- Decision date
- 2008-07-02
- Days to decision
- 55 days
- Clearance type
- Special
- Product code
- JHM
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072) | Dade Behring, Inc. | 2008-02-21 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |
| LDL CHOLESTEROL (AUTOMATED) (K022519) | Jas Diagnostics, Inc. | 2002-09-30 |
| DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE (K983849) | Dade Behring, Inc. | 1999-01-11 |
| ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935) | Roche Diagnostic Systems, Inc. | 1990-09-27 |
| HDL PRECIPITANT REAGENT SET (K841056) | Medical Specialties, Inc. | 1984-05-01 |
| LYPOPROTEIN CHOLESTEROL TEST KIT (K780173) | Environmental Chemical Specialties | 1978-05-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Si recall (Z-0089-2023) | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024) | Siemens Healthcare Diagnostics | 2025-10-17 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013) | Siemens Healthcare Diagnostics | 2025-10-17 |
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| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |