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510(k) K933589

Device
Boehringer Mannheim Tina-quant Transferrin Assay
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K933589
Product code
DDG
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-03
Date received
1993-07-26
Regulation
866.5880
Classification name
Transferrin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN D STEVENS
Address
9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K012371TINA-QUANT TRANSFERRIN VER.2Roche Diagnostics Corp.2001-09-19
K012393TINA-QUANT TRANSFERRIN VER.2Roche Diagnostics Corp.2001-09-19
K011662MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROLThe Binding Site, Ltd.2001-07-30