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510(k) K973367

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM by Radiometer America, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1997
Date Received
September 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

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  • K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (January 16, 1998)
  • K962158 — PICO MODELS 30, 50, 70 (October 29, 1996)
  • K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER (October 24, 1996)
  • K961354 — QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (June 14, 1996)

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