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510(k) K000586

BIOSCANNER TRIGLYCERIDES TEST STRIPS by Polymer Technology Systems, Inc. — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2000
Date Received
February 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)
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