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510(k) K123182

OSOM INFLUENZA A&B TEST MODEL 190 by SEKISUI Diagnostics, LLC — Product Code GNX

K123182 is an FDA 510(k) premarket notification submitted by SEKISUI Diagnostics, LLC for the device "OSOM INFLUENZA A&B TEST MODEL 190". The FDA issued a decision of Substantially Equivalent on November 5, 2012. The device falls under product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. SEKISUI Diagnostics, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2012
Date Received
October 10, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by SEKISUI Diagnostics, LLC

  • K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
  • K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
  • K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)

Other clearances for product code GNX

  • K133411 — ALERE BINAXNOW INFLUENZA A & B CARD (December 5, 2013)
  • K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST (August 22, 2013)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131599 — QUICK VUE INFLUENZA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • K924006 — BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (December 29, 1992)
  • K901493 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (June 27, 1990)
  • K893579 — FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (January 16, 1990)

FDA data resources