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510(k) K032194

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS by Gen-Probe, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2003
Date Received
July 18, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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  • K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (November 7, 2006)
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  • K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (August 17, 2006)
  • K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (July 25, 2006)
  • K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY (August 9, 2005)

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