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510(k) K842049

Device
FLUOROSKAN
Applicant
FLOW LABORATORIES, INC.
510(k) number
K842049
Product code
JZT  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-03
Date received
1984-05-22
Regulation
866.4520
Classification name
Fluorometer
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD A HAHN
Address
7655 Old Springhouse Rd. Mclean VA US 22102 22102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.1996-09-05
K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1988-09-07
K882677STAT-20 FLUOROMETERWeaver Medical1988-07-12
K864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.1986-12-22
K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.1986-10-29
K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, Inc.1986-08-15
K852240SMS, SCREEN MACHINE SYSTEMPandex Laboratories, Inc.1985-06-11
K843356FIAX 100 FLUOROMETERIntl. Diagnostic Technology1984-09-17
K834070IMMPULSE SYSTEMParagon Diagnostics, Inc.1984-03-23
K831870ALLERGENETICS FLUORO-FAST READERAxonics, Inc.1983-08-12
K800698AUTOFLUOR SYSTEMCalifornia Immuno Diagnostic, Inc.1980-05-28
K782150FLUROMETER, DADEDade, Baxter Travenol Diagnostics, Inc.1979-02-15
K770662VIEWER, FLUOROMETIC, MODEL 721Corning Medical & Scientific1977-04-15

Legacy Summary#

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FDA Review#

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