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510(k) K800003

CORTEX DOUBLE HELIX SAMPLER by Cortex Research Corp. — Product Code GLE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 1, 1980
Date Received: January 2, 1980
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mixer, Blood Tube
Device Class: Class I
Regulation Number: 862.2050
Review Panel: CH
Submission Type