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510(k) K092704

ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 by Abbott Molecular, Inc. — Product Code LSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2010
Date Received
September 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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Other clearances for product code LSK

  • K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (September 25, 2001)
  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K920302 — PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (April 6, 1994)
  • K920378 — PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (April 29, 1992)
  • K874878 — GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (December 29, 1987)
  • K871878 — RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (October 28, 1987)