DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
FDA 510(k) clearance K861700 · decided 1986-06-11
Clearance details
- K-number
- K861700
- Device name
- DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-05
- Decision date
- 1986-06-11
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog recall (Z-1816-2022) | Siemens Healthcare Diagnostics, Inc. | 2022-09-26 |
| Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PH recall (Z-1049-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-04-02 |