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510(k) K945491

SERIM(TM) BICARB PH REAGENT STRIPS by Serim Research Corp. — Product Code MNV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1995
Date Received
November 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Dialysate Ph Indicator
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code MNV

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  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K944051 — ABSORBALBE ANCHOR (August 2, 1995)