FDA.report

510(k) K823023

Device
KM-KAL L6
Applicant
KMN PRODUCTS, INC.
510(k) number
K823023
Product code
JIT  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-16
Date received
1982-10-13
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

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 JIT  

510(k)DeviceApplicantDecision date
K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics2017-05-16
K170938CalSet IGF-1Roche Diagnostics2017-04-26
K170160Abbott ARCHITECT Free T3Abbott Laboratories2017-02-15
K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.2017-01-12
K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.2017-01-12
K163078DC-UIBC-CALSekisui Diagnostics P.E.I., Inc.2016-12-08
K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc.2016-12-01
K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics2016-11-17
K160113ST AIA-PACK hsE2 Calibrator SetTosoh Bioscience, Inc.2016-02-17
K153417ST AIA-PACK PROG III Calibrator SetTosoh Bioscience, Inc.2015-12-18
K152526Elecsys Progesterone III CalSetRoche Diagnostics2015-10-02
K151566Abbott ARCHITECT Total T4 CalibratorsAbbott Laboratories2015-07-10
K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26

Legacy Summary

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FDA Review

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