FDA.reportPublic FDA data

510(k) K771867

Device
MYCOPLASMA DETECTION KIT
Applicant
BIOASSAY SYSTEMS RESEARCH CORP.
510(k) number
K771867
Product code
KPB  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-17
Date received
1977-10-03
Regulation
864.2360
Classification name
Media And Components, Mycoplasma Detection
Medical specialty
Hematology
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781874MYCOPLASMA ARGININI FITC (30-403-41)Flow Laboratories, Inc.1978-12-20
K781875STAIN KIT FOR CELL CULTURES (30-100-00)Flow Laboratories, Inc.1978-12-20
K781390MYCOPLASMA HYORHINIS (BTS-7)Flow Laboratories, Inc.1978-09-01

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