ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306— 510(k) K994439
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K994439 for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306, Substantially Equivalent on 2000-01-14. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code JHX
view all- K234005 — Access CK-MB
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
More clearances from Beckman Coulter, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.