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510(k) K862775

Device
ASSERACHROM B-TG KIT
Applicant
AMERICAN BIOPRODUCTS CO.
510(k) number
K862775
Product code
JBX  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-22
Date received
1986-07-22
Regulation
864.6675
Classification name
Aggregrometer, Platelet
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LOC B LE
Address
601 N. Jefferson Rd. Parsippany NJ US 07054 07054

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
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
K811290ARACHIDONIC ACIDBio/Data Corp.1981-07-27
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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