ARCHITECT STAT CK-MB IMMUNOASSAY— 510(k) K041596
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K041596 for ARCHITECT STAT CK-MB IMMUNOASSAY, Substantially Equivalent on 2004-07-21. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- 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
- Middletown, VA, 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 Fisher Diagnostics
view all- K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.