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510(k) K962037

IMAGEN RESPIRATORY SCREEN by Dako Diagnostics , Ltd. — Product Code GNW

K962037 is an FDA 510(k) premarket notification submitted by Dako Diagnostics , Ltd. for the device "IMAGEN RESPIRATORY SCREEN". The FDA issued a decision of Substantially Equivalent on December 26, 1996. The device falls under product code GNW (Antisera, Cf, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Dako Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 26, 1996
Date Received: May 24, 1996
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 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)
K942172 — INFLUENZA A ANTIGEN TEST (July 6, 1994)
K942174 — INFLUENZA B ANITGEN TEST (June 30, 1994)

510(k) K962037

Clearance Details

Device Classification

Other clearances by Dako Diagnostics , Ltd.

Other clearances for product code GNW

FDA data resources