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510(k) K902267

BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS by Phoenix Diagnostics, Inc. — Product Code CHL

K902267 is an FDA 510(k) premarket notification submitted by Phoenix Diagnostics, Inc. for the device "BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS". The FDA issued a decision of Substantially Equivalent on June 12, 1990. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Phoenix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1990
Date Received
May 21, 1990
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

Other clearances by Phoenix Diagnostics, Inc.

  • K023268 — PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (November 15, 2002)
  • K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (June 4, 2002)
  • K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (February 4, 2002)
  • K020129 — PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE (February 1, 2002)
  • K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (December 18, 2001)
  • K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER (November 7, 2001)
  • K012509 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMI (October 9, 2001)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K945860 — SPECTRUM CO-OXIMETER LINEARITY CONTROL (January 17, 1995)
  • K920285 — BLOOD GAS/ISE LINEARITY CONTROL (July 14, 1992)

Other clearances for product code CHL

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  • K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K203790 — GEM Premier 5000 (August 20, 2021)
  • K200986 — OPTI® B-Lac Cassette (August 2, 2021)

FDA data resources