FDA.reportPublic FDA data

510(k) K910800

Device
ADP REAGENT
Applicant
HELENA LABORATORIES
510(k) number
K910800
Product code
GHR  
Decision
Substantially Equivalent (SESE)
Decision date
1991-05-20
Date received
1991-02-25
Regulation
864.5700
Classification name
Reagent, Platelet Aggregation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAHelena Laboratories2007-02-23
K952252ADP REAGENT, MODIFIEDHelena Laboratories1995-09-08
K922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.1992-08-26
K910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena Laboratories1991-05-20
K910706COLLAGEN REAGENT CAT. NO. 5368Helena Laboratories1991-05-20
K910286PLATELET AGGREGATION REAGENTSMedical Diagnostic Technologies, Inc.1991-03-19
K900792RISTOCETINMedical Diagnostic Technologies, Inc.1990-03-27
K832428PLATELET AGGREGATION REAGENT SETHelena Laboratories1983-10-20
K820422PLATELET AGGREGOMETERSChrono-Log Corp.1982-03-16
K760198KIT, PLATELET AGGREGATION REAGENT (#390)Chrono-Log Corp.1976-07-19

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