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510(k) K872694

YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN by Sita, Inc. — Product Code GNW

K872694 is an FDA 510(k) premarket notification submitted by Sita, Inc. for the device "YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN". The FDA issued a decision of Substantially Equivalent on September 18, 1987. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Sita, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Sita, Inc.

  • K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (October 15, 1987)
  • K872693 — INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872699 — MUMPS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872701 — RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (September 18, 1987)
  • K872698 — ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872696 — PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872695 — PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872697 — PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)

Other clearances for product code GNW

  • K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (October 21, 2009)
  • K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
  • K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K061101 — D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (November 20, 2006)
  • K022713 — DFA RESPIRATORY VIRUS SCREENING & ID KIT (December 18, 2002)
  • K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (November 7, 2000)
  • K974302 — LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (April 8, 1998)
  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K942172 — INFLUENZA A ANTIGEN TEST (July 6, 1994)

FDA data resources