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510(k) K905144

ECLIPSE ICA GLUCOSE by Biotope, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
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)
  • K905601 — ECLIPSE ICA TRIGLYCERIDES (January 17, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • K905602 — ECLIPSE ICA BUN (January 16, 1991)

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