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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.
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