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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