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510(k) K895951

CHOLESTEROL TEST KIT by Elite Technology, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
October 11, 1989
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 Elite Technology, Inc.

  • K900733 — PROTEIN TEST FOR URINE AND CSF (July 10, 1990)
  • K901001 — URIC ACID TEST KIT (May 23, 1990)
  • K901090 — ELITECH GAMMA GT TEST KIT (March 29, 1990)
  • K895952 — TRIGLYCERIDES TEST KIT (January 11, 1990)

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