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KIS — Sera, Animal And Human Class I

FDA Device Classification

Classification Details

Product Code
KIS
Device Class
Class I
Regulation Number
864.2800
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881287cell culture laboratoriesANIMAL AND HUMAN SERAApril 5, 1988
K880471hyclone laboratoriesBOVINE CALF SERUM SUPPLEMENTED #A-2159April 4, 1988
K880470hyclone laboratoriesBOVINE CALF SERUM CATALOG #A-2119April 1, 1988
K872847candace laneSOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTAugust 10, 1987
K870580rjo biologicalsMLC NORMAL SERUMApril 8, 1987
K870938hyclone laboratoriesFETAL BOVINE SERUMMarch 31, 1987
K870467hyclone laboratoriesDEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151March 24, 1987
K870463hyclone laboratoriesDEFINED FETAL BOVINE SERUM #A-1111March 24, 1987
K870469hyclone laboratoriesDEFINED EQUINE SERUM #A-3311March 24, 1987
K870468hyclone laboratoriesADULT BOVINE SERUMMarch 24, 1987
K870465hyclone laboratories6/40 FETAL BOVINE SERUM #A-1110March 24, 1987
K870464hyclone laboratoriesCHARACTERIZED FETAL BOVINE SERUM #A-1115March 24, 1987
K870466hyclone laboratoriesDEFINED CALF BOVINE SERUM #A-2111March 24, 1987
K861817hazleton research productsHORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATEDMay 20, 1986
K861813hazleton research productsHUMAN AB SERUM - STERILE FILTEREDMay 20, 1986
K861815hazleton research productsBOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATEMay 20, 1986
K861812hazleton research productsHUMAN SERUM - STERILE FILTEREDMay 20, 1986
K861809hazleton research productsLAMB SERUM - STERILE FILTEREDMay 20, 1986
K861814hazleton research productsRHESUS MONKEY SERUM - STERILE FILTEREDMay 20, 1986
K861810hazleton research productsCHICKEN SERUM - STERILE FILTEREDMay 20, 1986