Cleared Traditional

SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

K010598 · Quantimetrix Corp. · Hematology

Mar 2001

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K010598 is an FDA 510(k) clearance for the SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on March 23, 2001, 23 days after receiving the submission on February 28, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K010598 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2001
Decision Date	March 23, 2001
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF