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510(k) K914226

Device
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K914226
Product code
JZB  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-19
Date received
1991-09-20
Regulation
874.4420
Classification name
Scissors, Ear
Medical specialty
Ear Nose & Throat
Review panel
Immunology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHRISTOPHER BENTSEN
Address
Du Pont-Bmp22/1152 Wilmington DE US 19880 19880

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870756VEIN GRAFT EAR SCISSORSTreace Medical, Inc.1987-03-03
K833603SCISSORS SHEA BELLUCCMicrotek Medical, Inc.1984-01-03
K822196EAR SCISSORSKelleher Corp.1982-08-30

Legacy Summary#

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FDA Review#

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