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510(k) K905145

ECLIPSE ICA CHOLESTEROL by Biotope, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by Biotope, Inc.

  • K910256 — ECLIPSE ICA TSH (February 22, 1991)
  • K910302 — ECLIPSE ICA ANALYZER (February 22, 1991)
  • K905601 — ECLIPSE ICA TRIGLYCERIDES (January 17, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • K905602 — ECLIPSE ICA BUN (January 16, 1991)
  • K905144 — ECLIPSE ICA GLUCOSE (January 4, 1991)

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  • K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (July 11, 2017)
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  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)