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510(k) K914462

Device
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
Applicant
SERONO-BAKER DIAGNOSTICS, INC.
510(k) number
K914462
Product code
JLS  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-23
Date received
1991-10-07
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
DAVID B THOMAS
Address
100 Cascade Dr. Allentown PA US 18103 18103

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

Legacy Summary#

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FDA Review#

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