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510(k) K120846

TRANSPORT CULTURE MEDIUM DEVICE by Puritan Medical Products, LLC — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2012
Date Received
March 20, 2012
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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  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)
  • K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - (November 27, 1996)