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510(k) K973055

Device
WAKO CH50 LINEARITY SET
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K973055
Product code
JIW  
Decision
Substantially Equivalent (SESE)
Decision date
1997-09-25
Date received
1997-08-15
Regulation
862.1150
Classification name
Calibrator, Surrogate
Medical specialty
Clinical Chemistry
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TONYA MALLORY
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.1997-02-20
K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.1991-04-03
K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.1990-10-04
K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.1990-07-03
K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.1989-06-21
K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, Inc.1988-12-14
K882220CALIBRATION KITKing Diagnostics, Inc.1988-08-02
K880654AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200American Research Products Co.1988-06-07
K880610UNIMETER CALIBRATION KITBoehringer Mannheim Corp.1988-03-24
K854028AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZERVerified Medical Research, Inc.1985-12-02
K851450FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TMFlow Cytometry Standards Corp.1985-09-16
K852260QUICK-CHEM CALIBRATION SETSeragen Diagnostics, Inc.1985-07-22
K812220NEPHELOMETRIC SOLID TURBIDITY STANDARDHyland Therapeutic Div., Travenol Laboratories1981-08-18
K801300DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)E.I. Dupont DE Nemours & Co., Inc.1980-07-08
K800304CENTRIFICHEM FILTER CALIBRATION SETUnion Carbide Corp.1980-03-12

Legacy Summary#

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FDA Review#

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