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510(k) K003204

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

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.

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  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (November 14, 1995)

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  • 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)
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  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K942172 — INFLUENZA A ANTIGEN TEST (July 6, 1994)
  • K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)