ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS— 510(k) K972004
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K972004 for ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS, Substantially Equivalent on 1997-06-16. 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.