FDA.reportPublic FDA data

510(k) K862109

Device
Enzymun Test Tbg
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K862109
Product code
CEE
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-30
Date received
1986-06-03
Regulation
862.1685
Classification name
Radioimmunoassay, Thyroxine-Binding Globulin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUE SMITH
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.1995-07-26
K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.1993-06-07
K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.1991-04-29
K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.1991-01-30
K900240DELFIA TBG KITPharmacia, Inc.1990-03-30
K896991ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.1990-03-01
K893469AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KITAmersham Corp.1989-08-15
K885034T-UPTAKE MICROASSAYDiamedix Corp.1989-02-02
K884201FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.1988-12-14
K874658TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)Technicon Instruments Corp.1987-12-18
K861735TIPSEP-TBG ASSAYNuclear Diagnostics, Inc.1986-06-13
K842167TBG RIASyncor Intl. Corp.1984-07-09
K842010THYROXINE-BINDING GLOBULIN RADIOUMMUNichols Institute Diagnostics1984-06-25
K841024VENTREZYME T4U IMMUNOASSAY T4UVentrex Laboratories, Inc.1984-05-09
K822684ENDAB THYROID UPTAKEImmunotech Corp.1982-10-08