SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL— 510(k) K010598

Name: FDA 510(k) clearance K010598
Creator: U.S. Food and Drug Administration
Published: 2001-03-23

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K010598 for SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL, Substantially Equivalent on 2001-03-23. Applicant: Quantimetrix Corp.. Device class: 2.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2001-02-28
Decision date: 2001-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redondo Beach, CA, US

Download summary PDF View on FDA.gov ↗

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