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510(k) K962265

Device
MLX MICROTITER PLATE LUMINOMETER
Applicant
DYNATECH LABORATORIES, INC.
510(k) number
K962265
Product code
JSE  
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-25
Date received
1996-06-12
Regulation
866.2320
Classification name
Culture Media, Multiple Biochemical Test
Medical specialty
Microbiology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LARRY POOL
Address
14340 Sullyfield Cir. Chantilly VA US 22021 22021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883996X-ACT LDC/INDPro-Lab, Inc.1988-10-12
K883995X-ACT UREA/TDAPro-Lab, Inc.1988-10-12
K880133MIL MEDIUMHardy Media1988-03-31
K880116MRVP BROTHHardy Media1988-03-31
K874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARLakewood Biochemical Co., Inc.1987-11-20
K871096CYSTINE TRYPTIC AGAR W/O CARBOHYDRATESbioMerieux, Inc.1987-04-03
K864674MICRODILUTION IDENTIFICATION PANELSAmerican Micro Scan1987-01-05
K862393BIOTIS LITMUS MILKOtisville Biotech, Inc.1986-07-03
K860412BIOTIS SIM MEDIUMOtisville Biotech, Inc.1986-02-24
K860413BIOTIS TSIOtisville Biotech, Inc.1986-02-24
K860414BIOTIS ORNITHINE INDOLE MOTILITY MEDIAOtisville Biotech, Inc.1986-02-24
K860415BIOTIS SIMMON CITRATE AGAROtisville Biotech, Inc.1986-02-24
K860194AUSTIN ENTERIC SYSTEMAustin Biological Laboratories1986-02-20
K850982CTAPI - NEISSERA SCREENAnalytical Products, Inc.1985-03-29
K850734DIFFERENTIAL CULTURE MEDIUMRoseville Medical Laboratoriesu1985-03-20

Legacy Summary#

summary

FDA Review#

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