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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
K973212diagnostic hybridsFRESH CELLS WI-38September 25, 1997
K973211diagnostic hybridsFRESH CELLS MV1LUSeptember 25, 1997
K973214diagnostic hybridsFRESH CELLS HFFSeptember 25, 1997
K973210diagnostic hybridsFRESH CELLS NCI H292September 25, 1997
K973209diagnostic hybridsFRESH CELLS VEROSeptember 25, 1997
K973213diagnostic hybridsFRESH CELLS LLC-MK2September 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
K962780diagnostic hybridsFRESHCELLS, HEP-2August 29, 1996
K962311diagnostic hybridsFRESHFROZENCELLSAugust 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