FDA.reportPublic FDA data

510(k) K920559

Device
Abbott Vertex Analyzer
Applicant
ABBOTT LABORATORIES
510(k) number
K920559
Product code
JJJ
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-19
Date received
1992-02-07
Regulation
862.2320
Classification name
Counter (Beta, Gamma) For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARIJANE SIDOTE
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JJJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.1996-08-16
K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.1995-03-30
K900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.1990-07-19
K896202MATRIX(TM)-96Canberra Industries, Inc.1990-01-02
K894902SOURCEREROakfield Instruments, Ltd.1989-10-17
K884091SOURCERERJohn Caunt Scientific , Ltd.1989-02-02
K884269SAMPLE IDENTIFICATION STATION MODEL 38010Icn Micromedic Systems1989-01-09
K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERLkb Instruments, Inc.1987-11-04
K872430ISO-DATA 500 SERIES GAMMA COUNTERIso-Data, Inc.1987-08-21
K872429ISO-DATA 100 SERIES GAMMA COUNTERIso-Data, Inc.1987-08-21
K870115BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERSBerthold Analytical Instruments, Inc.1987-03-31
K862206TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTERMicromedic Systems1986-08-04
K851164DENTOCULT CULTURE-PADDLEOrion Corp.1985-10-29
K851689GENESYS GAMMA COUNTERLaboratory Technologies, Inc.1985-08-07
K8524341208 BETACORD AND 1208 BETCORD MLkb Instruments, Inc.1985-08-02