FDA.reportPublic FDA data

510(k) K920207

Device
HERMLE Z230H
Applicant
LABNET INTL., INC.
510(k) number
K920207
Product code
GKG  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-09
Date received
1992-01-16
Regulation
864.6400
Classification name
Centrifuge, Hematocrit
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WALTER DEMSIA
Address
P.O. Box 841 Woodbridge NJ US 07095 07095

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
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
K813033CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGYBd Becton Dickinson Vacutainer Systems Preanalytic1982-04-09

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