Home / 510(k) Clearances / K192240

510(k) K192240

RAPIDPoint 500e Blood Gas System by Siemens Healthcare Diagnostics, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2020
Date Received
August 19, 2019
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

Other clearances by Siemens Healthcare Diagnostics, Inc.

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code CHL

  • 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)
  • K200107 — epoc Blood Analysis System (June 5, 2020)