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510(k) K893124

OLYMPUS PK(TM) TP by Fujirebio Diagnostics,Inc. — Product Code GMT

K893124 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "OLYMPUS PK(TM) TP". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
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 GMT

  • K971502 — SERODIA TP-PA (November 13, 1997)
  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K911266 — MODIFIED PK TP CONTROL (May 7, 1991)
  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 1991)
  • K896410 — CELLOGNOST SYPHILIS H (May 15, 1990)
  • K791897 — BACTO-HATTS (November 13, 1979)
  • K791457 — AGGLUTINOTEST-SYPHILIS (September 24, 1979)
  • K760098 — REAGENT, VDRL (August 3, 1976)

FDA data resources