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510(k) K905601

ECLIPSE ICA TRIGLYCERIDES by Biotope, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1991
Date Received
December 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Biotope, Inc.

  • K905145 — ECLIPSE ICA CHOLESTEROL (February 26, 1991)
  • K910256 — ECLIPSE ICA TSH (February 22, 1991)
  • K910302 — ECLIPSE ICA ANALYZER (February 22, 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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