FLUIDS PACK— 510(k) K944516
Substantially EquivalentAlko Diagnostic Corp.
FDA 510(k) clearance K944516 for FLUIDS PACK, Substantially Equivalent on 1994-11-02. Applicant: Alko Diagnostic Corp.. Device class: 2.
Clearance details
- Applicant
- Alko Diagnostic Corp.
- Product code
- Code JIT
- 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
Recent devices under product code JIT
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- 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)
- K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.