SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM— 510(k) K973742
Substantially EquivalentSendx Medical, Inc.
FDA 510(k) clearance K973742 for SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM, Substantially Equivalent on 1997-12-03. Applicant: Sendx Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sendx Medical, Inc.
- 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
- Carlsbad, 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 Sendx Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.