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510(k) K813339

Device
DIRECT FA CONJUGATE FOR LEGIONELLA SP
Applicant
SPRINGWOOD MICROBIOLOGICALS
510(k) number
K813339
Product code
LHL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-18
Date received
1981-11-24
Regulation
866.3300
Classification name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984123THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (EZeus Scientific, Inc.1999-01-11
K970149LEGIONELLA ELISA TEST SYSTEMZeus Scientific, Inc.1997-06-18
K963318LEGIONELLA IGG/IGM ELISA TEST SYSTEMArmkel, LLC1997-03-03
K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYPro-Lab, Inc.1992-07-28
K871328DU PONT LEGIONELLA URINARY ANTIGEN - RIA KITE.I. Dupont DE Nemours & Co., Inc.1987-09-02
K864006LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TESTMedical Diagnostic Technologies, Inc.1987-04-20
K854108POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIOMedical Diagnostic Technologies, Inc.1985-11-12
K852237LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KITGenetic Systems Corp.1985-08-22
K842683GENETIC SYS LEGIONELLA IMMUNOFLURORESGenetic Systems Corp.1984-08-02
K832896LEGIONELLA INDIRECT FLUORESCENT ANTIBODBiodan Medical Systems, Ltd.1983-10-14
K831760LEGIONELLA IFA KIT IBionetic Laboratory Products1983-08-08
K831026INDIRECT FLUORESCENT ANTIBODY REAGENTSZeus Technologies1983-06-22
K830820LEGIONELLA DFA KIT IBionetic Laboratory Products1983-06-08
K822859DIRECT FA CONJUGATE FOR LEGIONELLA SPPZeus Technologies1983-02-16
K822066LEGIONELLA PNEUMOPHILABiodan Medical Systems, Ltd.1982-09-21

Legacy Summary#

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FDA Review#

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