KIR · Class I · 21 CFR 864.2280

FDA Product Code KIR: Cells, Animal And Human, Cultured

Leading manufacturers include Proteins Intl., Inc., Viromed Laboratories, Inc. and Advanced Clinical Diagnostics.

170

Total

170

Cleared

75d

Avg days

1978

Since

FDA 510(k) Cleared Cells, Animal And Human, Cultured Devices (Product Code KIR)

170 devices

1–24 of 170

Cleared Sep 25, 1997

FRESH CELLS VERO

K973209

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Microbiology · 29d

Cleared Sep 17, 1997

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE

K971508

Bio-Whittaker, Inc., A Cambrex Co.

Diagnostic Hybrids, Inc.

Microbiology · 63d

Cleared Feb 04, 1997

MINK LUNG CELL CULTURE

FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES

K962306

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc.

Microbiology · 43d

Cleared Aug 29, 1996

FRESHFROZEN CELLS, HEP-2

K962782

Diagnostic Hybrids, Inc.

Vai Diagnostics, Inc.

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE

K951440

Viromed Laboratories, Inc.

Pathology · 420d

Cleared May 22, 1996

NCI-H292 CELL CULTURE

K951461

Viromed Laboratories, Inc.

PRIMARY MONKEY KIDNEY CELL CULTURE

PRIMARY RABBIT KIDNEY CELL CULTURE

HUMAN NEWBORN FORESKIN CELL CULTURE

FDA Product Code KIR: Cells, Animal And Human, Cultured

FDA 510(k) Cleared Cells, Animal And Human, Cultured Devices (Product Code KIR)

About Product Code KIR - Regulatory Context

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