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510(k) K952725

MULTICHECK by Radiometer America, Inc. — Product Code GLY

K952725 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "MULTICHECK". The FDA issued a decision of Substantially Equivalent on February 20, 1996. The device falls under product code GLY (Oximeter To Measure Hemoglobin), a Class II device regulated under 21 CFR 864.7500. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1996
Date Received
June 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter To Measure Hemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Radiometer America, Inc.

  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (January 10, 2000)
  • K991417 — ABL 735 ANALYZER (November 24, 1999)
  • K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (January 6, 1999)
  • K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (February 9, 1998)
  • 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)

Other clearances for product code GLY

  • K050014 — HEMONIR TM (May 5, 2005)
  • K993104 — STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND (December 2, 1999)
  • K955013 — NOVA CO-OXIMETER ANALYZER (April 25, 1996)
  • K895466 — AVL MODEL 912 CO-OXYLITE (November 6, 1989)

FDA data resources