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510(k) K844021

ISE REAGENTS FOR DEMAND ANALYZER by Advanced Biomedical Methods, Inc. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1984
Date Received
October 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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

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