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510(k) K844105

FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY by Bartels Immunodiagnostic Supplies, Inc.

K844105 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on December 6, 1984. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1984
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Bartels Immunodiagnostic Supplies, Inc.

  • K864776 — A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (December 31, 1986)
  • K861172 — ROTAVIRUS LATEX AGGLUTINATION ASSAY (July 1, 1986)
  • K860279 — CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT (May 13, 1986)
  • K855034 — AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (March 11, 1986)
  • K842830 — IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (November 26, 1985)
  • K852185 — RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (August 19, 1985)
  • K842833 — PMK PRIMARY MONKEY KIDNEY-CELLS (August 28, 1984)
  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (August 3, 1984)
  • K842330 — AMER. HISTO-ID SYS PRIMARY IGA 2720-21 (August 2, 1984)

FDA data resources