FDA 510(k) Applications Submitted by ALEX WESOLOWSKI

FDA 510(k) Number Submission Date Device Name Applicant
K973707 09/29/1997 ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE MOLECULAR SYSTEMS, INC.
K973718 09/29/1997 ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE MOLECULAR SYSTEMS, INC.
K964355 11/01/1996 ONTRAK TESTCUP 5 (MODIFICATION) ROCHE DIAGNOSTIC SYSTEMS, INC.
K964506 11/08/1996 ROCHE COBAS AMPLICOR ANALYZER ROCHE MOLECULAR SYSTEMS, INC.
K964507 11/08/1996 ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST ROCHE MOLECULAR SYSTEMS, INC.
K974342 11/18/1997 ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC.
K974503 11/28/1997 ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC.


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