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510(k) K800852

Device
Hemespec Check Set
Applicant
HELENA LABORATORIES
510(k) number
K800852
Product code
KRZ
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-02
Date received
1980-04-15
Regulation
864.8165
Classification name
Calibrator For Hemoglobin And Hematocrit Measurement
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 KRZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche Diagnostics2005-08-26
K041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.2004-06-10
K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.1996-12-18
K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.1995-07-24
K902892CELL-DYN CALIBRATORUnipath , Ltd.1990-09-10
K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, Inc.1990-01-25
K893984HGB-CAL SET/MULTIPLER&D Systems, Inc.1989-08-15
K883703MSI-CAL 7Medical Specialties, Inc.1988-11-22
K883850MSI-CAL 16Medical Specialties, Inc.1988-11-22
K883851MSI-CAL 8Medical Specialties, Inc.1988-11-22
K882600HEMOCUE HEMOGLOBIN CALIBRATORReact and Co.1988-07-18
K873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801In Vitro Diagnostics, Inc.1987-11-23
K871283CYANMETHEMOGLOBIN STANDARDU. S. Diagnostics, Inc.1987-04-15
K854166HEMATOLOGY CALIBRATOR CONTROLInterscience Diagnostics, Inc.1986-03-12
K842668LIQUI-HEME HEMOGLOBIN CALIBRATORSBiodiagnostic Intl1985-03-05