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510(k) K895102

Device
BIOTRACK PDS MONITOR
Applicant
BIOTRACK, INC.
510(k) number
K895102
Product code
JJQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-10
Date received
1989-08-15
Regulation
862.2300
Classification name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JILL FINDLAY
Address
1058 Huff Ave. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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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