FDA 510(k) Applications for Medical Device Product Code "KIR"
(Cells, Animal And Human, Cultured)

FDA 510(k) Number Applicant Device Name Decision Date
K971508 BIO-WHITTAKER, INC., A CAMBREX CO. RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE 09/17/1997
K973214 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS HFF 09/25/1997
K973213 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS LLC-MK2 09/25/1997
K962306 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES 08/29/1996
K973211 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS MV1LU 09/25/1997
K973210 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS NCI H292 09/25/1997
K973209 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS VERO 09/25/1997
K973212 DIAGNOSTIC HYBRIDS, INC. FRESH CELLS WI-38 09/25/1997
K972414 DIAGNOSTIC HYBRIDS, INC. FRESHCELLS 08/29/1997
K962780 DIAGNOSTIC HYBRIDS, INC. FRESHCELLS, HEP-2 08/29/1996
K962782 DIAGNOSTIC HYBRIDS, INC. FRESHFROZEN CELLS, HEP-2 08/29/1996
K962311 DIAGNOSTIC HYBRIDS, INC. FRESHFROZENCELLS 08/29/1996
K960909 NEOGENEX H292 CELL CULTURE 05/30/1996
K965047 NEOGENEX MINK LUNG CELL CULTURE 02/04/1997
K955608 VAI DIAGNOSTICS, INC. MCCOY CELL CULTURES 07/08/1996
K955921 VIRATEST INTL., INC. A549 CELL CULTURE 02/16/1996
K951440 VIROMED LABORATORIES, INC. LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE 05/22/1996
K951461 VIROMED LABORATORIES, INC. NCI-H292 CELL CULTURE 05/22/1996


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