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510(k) K854384

Device
ASSERACHROM FPA KIT
Applicant
AMERICAN BIOPRODUCTS CO.
510(k) number
K854384
Product code
DAN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-04
Date received
1985-10-30
Regulation
866.5350
Classification name
Fibrinopeptide A, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
B LE
Address
601 N. Jefferson Rd. Parsippany NJ US 07054 07054

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DAN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884496RIA/MAT FPA TEST KITAltana, Inc.1988-11-16
K821151RIA-QUANT FPA TEST KITMallinckrodt Critical Care1982-07-22

Legacy Summary#

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FDA Review#

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