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510(k) K812077

Device
Helena Sickle-thal Quik Column Method
Applicant
HELENA LABORATORIES
510(k) number
K812077
Product code
JPD
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-18
Date received
1981-07-22
Regulation
864.7400
Classification name
Hemoglobin A2 Quantitation
Medical specialty
Hematology
Review panel
Hematology
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 JPD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.2002-05-14
K991127VARIANT II B-THALASSEMIABio-Rad1999-06-10
K924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-Rad1993-03-11
K924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITDrew Scientific , Ltd.1992-11-16
K923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena Laboratories1992-08-25
K923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena Laboratories1992-08-25
K913384COLUMNMATE(TM) BETA-THAL CAT. NO. 4515Helena Laboratories1991-12-17
K896168HEMOGLOBIN A2 MICRO COLUMN TESTBio-Rad1990-01-18
K875102DETER. OF HEMOGLOBIN A2 USING THE DIAMATBio-Rad1988-02-24
K823870BETA THALQUIK COLUMN #5341Helena Laboratories1983-02-01
K803108HELENA HBA2 QUIK COLUMN METHODHelena Laboratories1981-01-09
K801410HEMOHLOBIN A2 CONTROL-LYOPHILIZEDIsolab, Inc.1980-07-21