THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS— 510(k) K962864
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K962864 for THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS, Substantially Equivalent on 1996-12-18. Applicant: Alko Diagnostic Corp.. Device class: 2.
Clearance details
- Applicant
- Alko Diagnostic Corp.
- Product code
- Code KRZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.8165
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
Recent devices under product code KRZ
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- K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44
- K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
- K970921 — STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
- K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.