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510(k) K855034

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT by Bartels Immunodiagnostic Supplies, Inc. — Product Code LIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1986
Date Received
December 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peroxidase Anti-Peroxidase Immunohistochemical Stain
Device Class
Class I
Regulation Number
864.4400
Review Panel
PA
Submission Type

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)
  • K842830 — IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (November 26, 1985)
  • K852185 — RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (August 19, 1985)
  • K844105 — FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY (December 6, 1984)
  • 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)

Other clearances for product code LIJ

  • K820336 — DAKO PAP KIT K509 (July 13, 1982)