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510(k) K811290

Device
ARACHIDONIC ACID
Applicant
BIO/DATA CORP.
510(k) number
K811290
Product code
JBX  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-27
Date received
1981-05-11
Regulation
864.6675
Classification name
Aggregrometer, Platelet
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JBX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932566AGGRO/LINK CONTROL SOFTWAREChrono-Log Corp.1993-11-02
K912774ARACHIDONIC ACIDHelena Laboratories1991-08-22
K881829PAT PLATELET AGGREGATION TESTStreck Laboratories, Inc.1988-07-01
K862775ASSERACHROM B-TG KITAmerican Bioproducts Co.1986-10-22
K851025AGGRO/LINK COMPUTER INTERFACEChrono-Log Corp.1985-06-12
K850592PLATELET AGGREGATION REAGENTChrono-Log Corp.1985-05-13
K832929RISTOCETIN PLATELET AGGREGA-REAGENT TESTSigma Chemical Co.1983-09-29
K830749PLATELET AGGREGOMETERChrono-Log Corp.1983-05-16
K821005PLATELET AGGREGATION PROFILER #PAP-4Bio/Data Corp.1982-06-01
K781710BUFFER, COLLAGEN REAGENT AND DILUENTDiagnostica, Inc.1978-10-24
K760159AGGREGOMETER, DUAL CHANNEL PLATELETChrono-Log Corp.1976-07-20

Legacy Summary#

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FDA Review#

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