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510(k) K854303

Device
MR 700 MICROPLATE READER 012-700-1000
Applicant
DYNATECH LABORATORIES, INC.
510(k) number
K854303
Product code
JJQ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-11-19
Date received
1985-10-25
Regulation
862.2300
Classification name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Clearance type
Traditional
Third party reviewed
No

Other 510(k) Records For Product Code JJQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.2001-12-21
K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.1998-02-06
K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.1998-02-04
K974762STAT TRACKSAwareness Technology, Inc.1998-01-28
K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.1996-11-05
K961183CBI 7520 READERColumbia Bioscience, Inc.1996-08-02
K962166ORIGEN ANALYZERIgen, Inc.1996-07-31
K955077ANTHOS 2010 READERAnthos Labtec, Inc.1995-12-04
K953710ELX808 AUTOMATED MICROPLATE READERSBio-Tek Instruments, Inc.1995-10-25
K953572ELX800UVBio-Tek Instruments, Inc.1995-10-19
K953005BILI-METEROlympic Medical Corp.1995-09-28
K9500295STRATEC SL 300 LIA-MATNichols Institute Diagnostics1995-08-02
K940486DIGENE DCR-1 LUMINOMETERDigene Diagnostics, Inc.1995-04-18
K942250BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READERBiowhittaker Molecular Applications, Inc.1995-04-04
K942361WHITSOFTBiowhittaker Molecular Applications, Inc.1995-04-04

Legacy Summary#

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FDA Review#

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