FDA 510(k), K050891, TOX A/B QUICK CHEK
FDA 510(k), K050891, TOX A/B QUICK CHEK
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510(K) Number: K050891
Device Name: TOX A/B QUICK CHEK
Manufacturer: TECHLAB, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/08/2005
Decision Date: 07/25/2005
Regulation Medical Specialty: Microbiology
Device Name: TOX A/B QUICK CHEK
Manufacturer: TECHLAB, INC.
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 04/08/2005
Decision Date: 07/25/2005
Regulation Medical Specialty: Microbiology