FDA 510(k) Applications Submitted by PATRICIA E BONNESS

FDA 510(k) Number Submission Date Device Name Applicant
K980736 02/25/1998 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST ACON LABORATORIES CO.
K951550 04/04/1995 CMV BRITE ANTIGENEMIA TEST KIT BIOTEST DIAGNOSTICS CORP.
K991650 05/13/1999 CMV BRITE TURBO KIT BIOTEST DIAGNOSTICS CORP.
K983090 09/03/1998 ACON MIDSTREAM PREGNANCY TEST ACON LABORATORIES, INC.
K983839 10/30/1998 BIOTEST ANTI-EBV RECOMBINANT BIOTEST DIAGNOSTICS CORP.
K983841 10/30/1998 BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG BIOTEST DIAGNOSTICS CORP.
K983842 10/30/1998 BIOTEST ANTI-EBV RECOMBINANT, EA IGM BIOTEST DIAGNOSTICS CORP.
K964609 11/18/1996 ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE ARRAY MEDICAL, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact