RIA-QUANT CK-MB TEST KIT— 510(k) K792504
Substantially EquivalentMallinckrodt Critical Care
FDA 510(k) clearance K792504 for RIA-QUANT CK-MB TEST KIT, Substantially Equivalent on 1980-01-16. Applicant: Mallinckrodt Critical Care. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Critical Care
- 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
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- 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 Mallinckrodt Critical Care
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