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510(k) K121445

TETRACHROME REAGENTS AND TETRACXP SYSTEM by Beckman Coulter, Inc. — Product Code OYE

K121445 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "TETRACHROME REAGENTS AND TETRACXP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2013. The device falls under product code OYE (Flow Cytometric Reagents And Accessories.), a Class II device regulated under 21 CFR 864.5220. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
May 15, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flow Cytometric Reagents And Accessories.
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

Other clearances by Beckman Coulter, Inc.

  • K252169 — Access BNP II (March 24, 2026)
  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (February 19, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)

Other clearances for product code OYE

  • K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels (November 22, 2023)
  • K201814 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurat (September 28, 2020)
  • K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), (July 3, 2017)
  • K162897 — Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 L (June 23, 2017)
  • K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMU (April 10, 2015)
  • K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow (February 27, 2015)
  • K130373 — NAVIOS FLOW CYTOMETER SYSTEM (September 18, 2013)

FDA data resources