FDA.reportPublic FDA data

510(k) K920230

Device
Affinity Prg
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K920230
Product code
JLS
Decision
Substantially Equivalent (SESE)
Decision date
1992-02-18
Date received
1992-01-17
Regulation
862.1620
Classification name
Radioimmunoassay, Progesterone
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
JUDITH SMITH
Address
P.O. Box 243 Cockeysville MD US 21030 21030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JLS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbH2004-07-22
K973898PROGESTERONE ELISAKmi Diagnostics, Inc.1997-11-13
K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.1997-06-24
K971725OPUS PROGESTERONEBehring Diagnostics, Inc.1997-06-18
K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.1997-03-24
K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, Inc.1997-01-09
K955025AXSYM PROGESTERONEAbbott Laboratories1996-03-07
K955769ACCESS PROGESTERONE ASSAYBio-Rad Laboratories, Inc.1996-02-05
K952075PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEMBayer Corp.1995-06-13
K951630AURAFLEX PROGESTERONE 150TEST PACKOrganon Teknika Corp.1995-05-08
K950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYBaxter Diagnostics, Inc.1995-04-11
K944211IMMULITE PROGESTERONEDiagnostic Products Corp.1994-12-19
K935138IMMULITE PROGESTERONEDiagnostic Products Corp.1994-01-11
K933128SYNELISA PROGESTERONEElias U.S.A., Inc.1993-11-05
K933269AIA-PACK(R) PROG ASSAYTosoh Medics, Inc.1993-10-22