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510(k) K894265

Device
DSL 17A-OH PROGERSTERONE (DSL #6800)
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
510(k) number
K894265
Product code
JLX  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-07
Date received
1989-06-22
Regulation
862.1395
Classification name
Radioimmunoassay, 17-hydroxyprogesterone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHNNY WILLIS
Address
445 Medical Center Blvd. Webster TX US 77598 77598

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JLX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UWallac OY2010-07-23
K081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY2009-04-16
K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEDrg Intl., Inc.2008-01-29
K060452ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAHNeo-Genesis2007-03-13
K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITWallac OY2005-07-11
K042425AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY2004-09-30
K042424DELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY2004-09-30
K973350BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TESTBio-Rad1998-02-09
K934178ACCUSCREEN 17-HYDROXYPROGESTERONENeometrics, Inc.1995-03-30
K940233NEOSCREEN ELISA HYDROXYPROGESTERONEPantex1994-12-28
K943148DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)Diagnostic Systems Laboratories, Inc.1994-11-10
K912026DELFIA(R) 17 -OH-PROGESTERON KITPharmacia Diagnostics, Inc.1991-06-25
K911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITPantex, Div. Bio-Analysis, Inc.1991-06-18
K88519817-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIAIcn Biomedicals, Inc.1989-02-23
K874782COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KITDiagnostic Products Corp.1988-02-11

Legacy Summary#

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FDA Review#

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