DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM— 510(k) K861700
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K861700 for DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM, Substantially Equivalent on 1986-06-11. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code CHH
view allMore clearances from E.I. Dupont DE Nemours & Co., Inc.
view allRecalls naming K861700
K-number listed on FDA's recall record- Z-1816-2022 — Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
- Z-1049-2013 — Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K861700.
Data sourced from openFDA. This site is unofficial and independent of the FDA.