Atlas FDA

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

FDA 510(k) clearance K974302 · decided 1998-04-08

Clearance details

K-number
K974302
Device name
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
Applicant
Light Diagnostics
Decision
Substantially Equivalent
Date received
1997-11-17
Decision date
1998-04-08
Days to decision
142 days
Clearance type
Traditional
Product code
GNW
Device class
1
Regulation number
866.3330
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Temecula, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204)Intracel Corp.2000-11-07
IMAGEN RESPIRATORY SCREEN (K973954)Dako Diagnostics , Ltd.1997-12-22
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
INFLUENZA A ANTIGEN TEST (K942172)Neogenex1994-07-06
INFLUENZA B ANITGEN TEST (K942174)Neogenex1994-06-30
INFLUENZA MAB TEST/INFLUENZA A TEST (K913351)Gull Laboratories, Inc.1991-12-17
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Recalls involving this device

RecordFirmDate
LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FO recall (Z-0953-2009)Millipore Corporation2009-03-06
LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a componen recall (Z-0954-2009)Millipore Corporation2009-03-06