HICHEM ISE DILUENT KIT 70008— 510(k) K953860
Substantially EquivalentHichem Diagnostics
FDA 510(k) clearance K953860 for HICHEM ISE DILUENT KIT 70008, Substantially Equivalent on 1995-09-06. Applicant: Hichem Diagnostics. Device class: 2.
Clearance details
- Applicant
- Hichem Diagnostics
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code CGZ
view all- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K170320 — Alinity c ICT Sample Diluent
- K162020 — VITROS Chemistry Products Cl- Slides
- K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
- K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
More clearances from Hichem Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.