SIGMA PROCEDURE NO. 745 - EP.REAGENT SY— 510(k) K760591
Substantially EquivalentSigma Chemical Co.
FDA 510(k) clearance K760591 for SIGMA PROCEDURE NO. 745 - EP.REAGENT SY, Substantially Equivalent on 1976-10-29. Applicant: Sigma Chemical Co.. Device class: 2.
Clearance details
- Applicant
- Sigma Chemical Co.
- 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
- Mchenry, IL, 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 Sigma Chemical Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.