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510(k) K973707

ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS by Roche Molecular Systems, Inc. — Product Code MKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1999
Date Received
September 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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