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510(k) K915454

CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT by Medical Packaging Corp. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1992
Date Received
December 5, 1991
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)
  • 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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  • K082472 — VIROCULT, MODEL MW950 (December 30, 2008)
  • K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL (July 30, 2007)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)
  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)