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510(k) K924006

BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY by Baxter Healthcare Corp — Product Code GNX

K924006 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 29, 1992. 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. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1992
Date Received
August 10, 1992
Clearance Type
Traditional
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

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  • K190910 — PrisMax System Version 2 (July 25, 2019)
  • K163530 — PrisMax Control Unit (May 3, 2017)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

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)
  • K123182 — OSOM INFLUENZA A&B TEST MODEL 190 (November 5, 2012)
  • K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (September 10, 1997)
  • 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