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510(k) K163534

Lumipulse G FSH-N Calibrators by Fujirebio Diagnostics,Inc. — Product Code JIT

K163534 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "Lumipulse G FSH-N Calibrators". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2017
Date Received
December 16, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Fujirebio Diagnostics,Inc.

  • K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 (December 16, 2025)
  • K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (May 16, 2025)
  • DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40) (May 4, 2022)
  • K192524 — Lumipulse G CA15-3 (September 4, 2020)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)
  • K160113 — ST AIA-PACK hsE2 Calibrator Set (February 17, 2016)

FDA data resources