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510(k) K003204

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT by Intracel Corp. — Product Code GNW

K003204 is an FDA 510(k) premarket notification submitted by Intracel Corp. for the device "BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT". The FDA issued a decision of Substantially Equivalent on November 7, 2000. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Intracel Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2000
Date Received
October 13, 2000
Clearance Type
Special
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 Intracel Corp.

  • K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (December 21, 1999)
  • K990664 — PRIMA SYSTEM - OLD, BARTELS ELISA - NEW (March 31, 1999)
  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (November 14, 1995)

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)
  • 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