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KIS — Sera, Animal And Human Class I

FDA Device Classification

FDA product code KIS covers "Sera, Animal And Human", a Class I medical device regulated under 21 CFR 864.2800. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
KIS
Device Class
Class I
Regulation Number
864.2800
Submission Type
510(k) Exempt
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K881287Cell Culture LaboratoriesANIMAL AND HUMAN SERAApr 5, 1988
K880471Hyclone LaboratoriesBOVINE CALF SERUM SUPPLEMENTED #A-2159Apr 4, 1988
K880470Hyclone LaboratoriesBOVINE CALF SERUM CATALOG #A-2119Apr 1, 1988
K872847Candace LaneSOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTAug 10, 1987
K870580Rjo BiologicalsMLC NORMAL SERUMApr 8, 1987
K870938Hyclone LaboratoriesFETAL BOVINE SERUMMar 31, 1987
K870469Hyclone LaboratoriesDEFINED EQUINE SERUM #A-3311Mar 24, 1987
K870465Hyclone Laboratories6/40 FETAL BOVINE SERUM #A-1110Mar 24, 1987
K870467Hyclone LaboratoriesDEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151Mar 24, 1987
K870463Hyclone LaboratoriesDEFINED FETAL BOVINE SERUM #A-1111Mar 24, 1987
K870466Hyclone LaboratoriesDEFINED CALF BOVINE SERUM #A-2111Mar 24, 1987
K870464Hyclone LaboratoriesCHARACTERIZED FETAL BOVINE SERUM #A-1115Mar 24, 1987
K870468Hyclone LaboratoriesADULT BOVINE SERUMMar 24, 1987
K861810Hazleton Research ProductsCHICKEN SERUM - STERILE FILTEREDMay 20, 1986
K861815Hazleton Research ProductsBOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATEMay 20, 1986
K861813Hazleton Research ProductsHUMAN AB SERUM - STERILE FILTEREDMay 20, 1986
K861811Hazleton Research ProductsMOUSE SERUM - STERILE FILTEREDMay 20, 1986
K861814Hazleton Research ProductsRHESUS MONKEY SERUM - STERILE FILTEREDMay 20, 1986
K861812Hazleton Research ProductsHUMAN SERUM - STERILE FILTEREDMay 20, 1986
K861809Hazleton Research ProductsLAMB SERUM - STERILE FILTEREDMay 20, 1986

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.