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510(k) K884496

Device
RIA/MAT FPA TEST KIT
Applicant
ALTANA, INC.
510(k) number
K884496
Product code
DAN  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-16
Date received
1988-10-25
Regulation
866.5350
Classification name
Fibrinopeptide A, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CLAIR, PHD
Address
60 Baylis Rd. Melville NY US 11747 11747

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
K854384ASSERACHROM FPA KITAmerican Bioproducts Co.1986-02-04
K821151RIA-QUANT FPA TEST KITMallinckrodt Critical Care1982-07-22

Legacy Summary#

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FDA Review#

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