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510(k) K964507

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST by Roche Molecular Systems, Inc. — Product Code MKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
November 8, 1996
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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