FDA.reportPublic FDA data

510(k) K922792

Device
ZITHROMAX
Applicant
DIFCO LABORATORIES, INC.
510(k) number
K922792
Product code
JNT  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-30
Date received
1992-06-09
Regulation
862.1575
Classification name
Chromatographic, Phospholipids
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID W GATES
Address
P. O. Box 331058 Detroit MI US 48232 48232

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
K914040PHOSPHOLIPID REAGENT SETSterling Diagnostics, Inc.1991-10-30
K792349SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.Pfizer, Inc.1980-03-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases