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Bartels Immunodiagnostic Supplies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSDecember 31, 1986
K861172ROTAVIRUS LATEX AGGLUTINATION ASSAYJuly 1, 1986
K860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITMay 13, 1986
K855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTMarch 11, 1986
K842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFNovember 26, 1985
K852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANTAugust 19, 1985
K844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODYDecember 6, 1984
K842833PMK PRIMARY MONKEY KIDNEY-CELLSAugust 28, 1984
K842834HEP-2 CELLSAugust 28, 1984
K842328AMER. HISTO-ID SYS PRIMARY LAMBDA CHAINAugust 3, 1984
K842326AMER. HISTO-ID SYS PRIMARY KITAugust 2, 1984
K842329AMER. HISTO-ID SYS PRIMARY IGG S7920-11August 2, 1984
K842327AMER. HISTO-ID SYS PRIMARY IGM S7920-31August 2, 1984
K842330AMER. HISTO-ID SYS PRIMARY IGA 2720-21August 2, 1984
K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITJuly 20, 1984
K841998IMR-90-DIPLOID-HUMAN FETAL LUNG CELLJune 27, 1984
K842000PRIMARY RABBITT KIDNEY CELL CULTUREJune 22, 1984
K841999BGM CELL CULTURE AFRICAN GREEN MONKEYJune 22, 1984
K840744TRANSPORTER VIRAL TRANSPORT MEDIUMJune 7, 1984
K833447CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-May 21, 1984