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510(k) K863103

PEG 6,000 by J. D. Assoc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
August 13, 1986
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 J. D. Assoc.

  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863109 — FERROFAST (November 24, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)
  • K863102 — GLUCOMETER-E (November 24, 1986)

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