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510(k) K992859

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE by Radiometer America, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2000
Date Received
August 25, 1999
Clearance Type
Special
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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  • K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (January 28, 1998)
  • K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (January 16, 1998)
  • K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (October 6, 1997)
  • 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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