Medical Device Manufacturer · US , Mchenry , IL

Bartels Immunodiagnostic Supplies, Inc. - FDA 510(k) Cleared Devices

35 submissions · 34 cleared · Since 1981

Recent clearances: A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS, ROTAVIRUS LATEX AGGLUTINATION ASSAY, CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT

35

Total

34

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bartels Immunodiagnostic Supplies, Inc. Pathology ✕

10 devices

1-10 of 10

Cleared Dec 31, 1986

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS

Pathology · 23d

Cleared Mar 11, 1986

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT

Pathology · 84d

Cleared Mar 23, 1984

TISSUE CULTURE REFEEDING MEDIUM

Pathology · 115d

Cleared Mar 22, 1984

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN

Pathology · 114d

Cleared Mar 22, 1984

Pathology · 114d

Cleared Mar 22, 1984

LLC-MK2-RHESUS MONKEY KIDNEY CELLS

Pathology · 114d

Cleared Mar 22, 1984

WI-38 HUMAN LUNG CELLS

Pathology · 114d

Cleared Mar 22, 1984

Pathology · 114d

Cleared Mar 22, 1984

Pathology · 114d

Cleared Mar 22, 1984

PBS W/MG+2 & CA+2

Pathology · 113d