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KIR — Cells, Animal And Human, Cultured Class I

FDA Device Classification

Classification Details

Product Code
KIR
Device Class
Class I
Regulation Number
864.2280
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K973211diagnostic hybridsFRESH CELLS MV1LUSeptember 25, 1997
K973213diagnostic hybridsFRESH CELLS LLC-MK2September 25, 1997
K973210diagnostic hybridsFRESH CELLS NCI H292September 25, 1997
K973214diagnostic hybridsFRESH CELLS HFFSeptember 25, 1997
K973209diagnostic hybridsFRESH CELLS VEROSeptember 25, 1997
K973212diagnostic hybridsFRESH CELLS WI-38September 25, 1997
K971508bio-whittaker, inc., a cambrexRHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURESeptember 17, 1997
K972414diagnostic hybridsFRESHCELLSAugust 29, 1997
K965047neogenexMINK LUNG CELL CULTUREFebruary 4, 1997
K962782diagnostic hybridsFRESHFROZEN CELLS, HEP-2August 29, 1996
K962311diagnostic hybridsFRESHFROZENCELLSAugust 29, 1996
K962780diagnostic hybridsFRESHCELLS, HEP-2August 29, 1996
K962306diagnostic hybridsFRESH CELLS MULTI-WELL & SHELL VIAL CULTURESAugust 29, 1996
K955608vai diagnosticsMCCOY CELL CULTURESJuly 8, 1996
K960909neogenexH292 CELL CULTUREMay 30, 1996
K951440viromed laboratoriesLLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTUREMay 22, 1996
K951461viromed laboratoriesNCI-H292 CELL CULTUREMay 22, 1996
K955921viratest intlA549 CELL CULTUREFebruary 16, 1996
K952727viratest intlMRC-5 CELL CULTURE VIALNovember 20, 1995
K942820bartelsH292May 5, 1995