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FDA 510(k) Applications Submitted by DOROTHY DEINZER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K030329
01/31/2003
FASTPACK FREE T4 IMMUNOASSAY
Qualigen, Inc.
K021972
06/17/2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
Qualigen, Inc.
K022533
07/31/2002
FASTPACK TESTOSTERONE CALIBRATOR
Qualigen, Inc.
K003094
10/03/2000
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Qualigen, Inc.
K003095
10/03/2000
FASTPACK CONTROL
Qualigen, Inc.
K003096
10/03/2000
FASTPACK CALIBRATORS
Qualigen, Inc.
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