FDA.reportPublic FDA data

510(k) K931374

Device
AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
Applicant
MICROPROBE CORP.
510(k) number
K931374
Product code
MLA  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-15
Date received
1993-03-18
Regulation
866.2660
Classification name
Dna Probe, Yeast
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RUSSEL K ENNS
Address
1725 220th St., SE, 104 Bothell WA US 98021 98021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MLA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931151AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDAMicroprobe Corp.1993-06-18

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