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510(k) K082352

SERIM DISINTEK OPA TEST STRIP by Serim Research Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2008
Date Received
August 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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  • K043031 — SERIM DIALYSATE MONITOR TEST STRIP (June 13, 2005)
  • K014038 — PYLORITEK VP TEST KIT 5140VP (February 8, 2002)
  • K012115 — SERIM BLOOD LEAK TEST STRIP-2 (November 30, 2001)

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