ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44— 510(k) K982501
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K982501 for ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44, Substantially Equivalent on 1998-09-01. Applicant: Alko Diagnostic Corp.. Device class: 2.
Clearance details
- Applicant
- Alko Diagnostic Corp.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.