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510(k) K970597

CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) by Medical Packaging Corp. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1997
Date Received
February 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances by Medical Packaging Corp.

  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K972726 — SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (October 8, 1997)
  • K964637 — CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (December 24, 1996)
  • K932337 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM (August 16, 1994)
  • K936078 — CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED (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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