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510(k) K092882

D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT by Diagnostic Hybrids, Inc. — Product Code GNW

K092882 is an FDA 510(k) premarket notification submitted by Diagnostic Hybrids, Inc. for the device "D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT". The FDA issued a decision of Substantially Equivalent on October 21, 2009. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Diagnostic Hybrids, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2009
Date Received
September 18, 2009
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 Diagnostic Hybrids, Inc.

  • DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (December 23, 2009)
  • K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (December 4, 2009)
  • K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (September 11, 2009)
  • K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)
  • K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (March 6, 2009)
  • K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)

Other clearances for product code GNW

  • 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)
  • K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)

FDA data resources