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510(k) K910706

Device
COLLAGEN REAGENT CAT. NO. 5368
Applicant
HELENA LABORATORIES
510(k) number
K910706
Product code
GHR  
Decision
Substantially Equivalent (SESE)
Decision date
1991-05-20
Date received
1991-02-20
Regulation
864.5700
Classification name
Reagent, Platelet Aggregation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAHelena Laboratories2007-02-23
K952252ADP REAGENT, MODIFIEDHelena Laboratories1995-09-08
K922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.1992-08-26
K910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena Laboratories1991-05-20
K910800ADP REAGENTHelena Laboratories1991-05-20
K910286PLATELET AGGREGATION REAGENTSMedical Diagnostic Technologies, Inc.1991-03-19
K900792RISTOCETINMedical Diagnostic Technologies, Inc.1990-03-27
K832428PLATELET AGGREGATION REAGENT SETHelena Laboratories1983-10-20
K820422PLATELET AGGREGOMETERSChrono-Log Corp.1982-03-16
K760198KIT, PLATELET AGGREGATION REAGENT (#390)Chrono-Log Corp.1976-07-19

Legacy Summary#

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FDA Review#

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