FDA.reportPublic FDA data

510(k) K973938

Device
Alpha 4 Ls Automated Microtiterplate Processor And Reader
Applicant
SFRI, INC.
510(k) number
K973938
Product code
JJQ
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-04
Date received
1997-10-15
Regulation
862.2300
Classification name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GERALD ODSTRCHEL
Address
2082 Michelson Dr., #100 Irvine CA US 92612 92612

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
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
K942245BIOWHITTAKER 2001 MICROPLATE READER FIRMWAREBiowhittaker Molecular Applications, Inc.1995-04-03