Medical Device Manufacturer · US , Mchenry , IL

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

35 submissions · 34 cleared · Since 1981

35

Total

34

Cleared

0

Denied

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

16 devices

1-12 of 16

Cleared Jul 01, 1986

ROTAVIRUS LATEX AGGLUTINATION ASSAY

Microbiology · 95d

Cleared May 13, 1986

CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT

Microbiology · 119d

Cleared Nov 26, 1985

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF

Microbiology · 494d

Cleared Aug 19, 1985

RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT

Microbiology · 91d

Cleared Jul 20, 1984

CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT

Microbiology · 51d

Cleared Jun 27, 1984

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL

Microbiology · 42d

Cleared Jun 22, 1984

BGM CELL CULTURE AFRICAN GREEN MONKEY

Microbiology · 37d

Cleared Jun 22, 1984

PRIMARY RABBITT KIDNEY CELL CULTURE

Microbiology · 37d

Cleared Jun 07, 1984

TRANSPORTER VIRAL TRANSPORT MEDIUM

Microbiology · 105d

Cleared May 21, 1984

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-

Microbiology · 229d

Cleared Apr 20, 1984

DEAE-DEXTRAN IN PBS

Microbiology · 143d

Cleared Mar 23, 1984

CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT

Microbiology · 115d