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510(k) K833447

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- by Bartels Immunodiagnostic Supplies, Inc. — Product Code MCB

K833447 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
October 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, C. Difficile
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
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)
  • 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)
  • 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)

Other clearances for product code MCB

  • K132010 — VIDAS C DIFFICILE GDH (October 9, 2013)
  • K112048 — IMMUNOCARD C. DIFFICILE GDH (December 16, 2011)
  • K110620 — PREMIER C. DIFFICILE GDH (May 3, 2011)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)
  • K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (March 20, 1998)
  • K955067 — CLEARVIEW C. DIFF A (September 13, 1996)
  • K924062 — MERITEC C. DIFFICILE CONTROLS (October 19, 1992)
  • K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (March 12, 1991)
  • K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (March 12, 1990)

FDA data resources