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510(k) K952621

EML105 ELECTROLYTE METABOLITE ANALYZER by Radiometer America, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1995
Date Received
June 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K962158 — PICO MODELS 30, 50, 70 (October 29, 1996)
  • K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER (October 24, 1996)

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