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510(k) K952075

Device
Progesterone Assay For The Technicon Immuno 1 System In-bitro Diagnostic System
Applicant
BAYER CORP.
510(k) number
K952075
Product code
JLS
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-13
Date received
1995-05-03
Regulation
862.1620
Classification name
Radioimmunoassay, Progesterone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GABRIEL J MURACA, JR.
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K931228PROGESTERONE RADIOIMMUNOASSAY KITImmunotech Corp.1993-10-22