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510(k) K003761

NAT - NUCLEIC ACID TRANSPORT by Medical Packaging Corp. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2001
Date Received
December 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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  • K964637 — CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (December 24, 1996)
  • K936078 — CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED (August 16, 1994)
  • K932337 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM (August 16, 1994)
  • K915454 — CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (April 8, 1992)
  • K881105 — CULTURE COLLECTION DEVICE (April 25, 1988)
  • K870398 — PAP-PAK CYTOBRUSH KIT (February 25, 1987)
  • K864323 — CYTOLOGY BRUSHES (January 9, 1987)

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