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510(k) K771586

CHOLOPAP-HDL by Advanced Biomedical Methods, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 18, 1977
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

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  • K852783 — SGOT/ALT REAGENT (July 22, 1985)
  • K852027 — GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (May 29, 1985)
  • K850378 — LDH REAGENT FOR DEMAND ANALYZER (March 1, 1985)
  • K850379 — DIRECT BILIRUBIN FOR DEMAND ANALYZER (March 1, 1985)
  • K850381 — MAGNESIUM REAGENT FOR DEMAND ANALYZER (March 1, 1985)
  • K850380 — INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER (March 1, 1985)

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