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510(k) K792349

Device
SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.
Applicant
PFIZER, INC.
510(k) number
K792349
Product code
JNT  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-12
Date received
1979-11-19
Regulation
862.1575
Classification name
Chromatographic, Phospholipids
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JNT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922792ZITHROMAXDifco Laboratories, Inc.1992-07-30
K914040PHOSPHOLIPID REAGENT SETSterling Diagnostics, Inc.1991-10-30

Legacy Summary#

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FDA Review#

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