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