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510(k) K813039

ULTRACHEM E-CHOL, ITEM #65025 by Harleco — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
October 28, 1981
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 Harleco

  • K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056) (February 12, 1982)
  • K813427 — ULTRACHEM GLUC-DH (December 31, 1981)
  • K813044 — ULTRACHEM ALB, ITEM #64970 (November 10, 1981)
  • K813040 — ULTRACHEM CA, ITEM #64975 (November 10, 1981)
  • K813038 — ULTRACHEM TP, ITEM #64974 (November 10, 1981)
  • K813043 — ULTRACHEM CREA ITEM #64972 (November 10, 1981)
  • K813041 — ULTRAZYME-GT, ITEM #64959 & 65032 (November 10, 1981)
  • K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048 (November 10, 1981)
  • K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (October 2, 1981)
  • K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031 (October 2, 1981)

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