FDA.reportPublic FDA data

510(k) K841183

Device
SODIUM CHLORIDE SOLUTION BLOOD CELL
Applicant
REAGENT LABORATORY, INC.
510(k) number
K841183
Product code
FNW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-21
Date received
1984-03-20
Regulation
878.4370
Classification name
Pad, Kelly
Medical specialty
General & Plastic Surgery
Review panel
Hematology
Device class
2
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 FNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831117MICROMAT W/VARIOUS MODELSPmt, Inc.1984-05-30

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