FDA.reportPublic FDA data

510(k) K870351

Device
EZ COMPLEMENT REAGENTS, 78N2212
Applicant
DIAMEDIX CORP.
510(k) number
K870351
Product code
DHL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-13
Date received
1987-01-29
Regulation
866.4100
Classification name
Protein, Complement, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KIEFER, PHD
Address
2140 N. Miami Ave. Miami FL US 33127 33127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DHL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811445KALLESTAD R QUANTIPLATE ALT. PATHWAY T.Kallestad Laboratories, Inc.1981-06-24
K811433SCRIPPSERA COMPLEMENT CONTROL SERAScripps-Miles, Inc.1981-06-16
K770866RABBIT COMPLEMENTCedarlake Labs , Ltd.1977-06-03

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