FDA.reportPublic FDA data

510(k) K813033

Device
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K813033
Product code
GKG  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-09
Date received
1981-10-28
Regulation
864.6400
Classification name
Centrifuge, Hematocrit
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.1996-07-05
K955795MULTI-CENTRIFUGENovonx, Inc.1996-03-29
K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLC1993-03-23
K925863SPUNCRITbioMerieux, Inc.1993-02-05
K920207HERMLE Z230HLabnet Intl., Inc.1992-06-09
K920759CRITSPIN MICRO-HEMATOCRITStat-Spin Technologies1992-04-29
K913128HEMATASTAT C-70BSeparation Technology, Inc.1991-09-23
K890849HEMATASTAT H-70Separation Technology, Inc.1989-03-21
K821803QBC CENTRIFUGAL HEMATOLOGY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1982-09-14
K822445HCT CENTRIFUGEBoehringer Mannheim Corp.1982-09-14

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