STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)— 510(k) K970921
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K970921 for STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0), Substantially Equivalent on 1997-04-08. 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.