ACE II (TRI-LEVEL)— 510(k) K863095
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K863095 for ACE II (TRI-LEVEL), Substantially Equivalent on 1986-09-26. Applicant: Medical Analysis Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
Recent devices under product code JIX
view all- K161140 — VITROS Chemistry Products Calibrator Kit 3
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
More clearances from Medical Analysis Systems, Inc.
view all- K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
- K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
- K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
- K032826 — MAS PAR TDM
- K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
Data sourced from openFDA. This site is unofficial and independent of the FDA.