ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS— 510(k) K963734
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K963734 for ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS, Substantially Equivalent on 1996-10-24. Applicant: Alko Diagnostic Corp.. Device class: 2.
Clearance details
- Applicant
- Alko Diagnostic Corp.
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- 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.