FDA.reportPublic FDA data

510(k) K932482

Device
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
Applicant
MEDIX BIOTECH, INC.
510(k) number
K932482
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-18
Date received
1993-05-24
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN CHEN
Address
420 Lincoln Centre Dr. Foster City CA US 94404 94404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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