Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Test System NameINTRACEL Bartels Cytotoxicity Assay for C. difficile  (direct Ag)
Document NumberK833447
Parent Document NumberK833447
Analyte NameClostridium difficile
Analyte SpecialtyBacteriology
ComplexityHIGH
Effective Date01/18/2000
Device Classification Name Antigen, C. Difficile
510(k) Number K833447
Device Name CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
Applicant
Bartels Immunodiagnostic Supplies, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2660
Classification Product Code
MCB  
Date Received10/05/1983
Decision Date 05/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-