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510(k) K253863

GUARDIAN™ Quick Dip Residual Chlorine (5212) by Serim Research — Product Code FKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2026
Date Received
December 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FKJ

  • K901734 — SERIM RESIDUAL CHLORINE TEST KIT (September 13, 1990)
  • K841307 — BBL GASPAK POUCH (May 14, 1984)
  • K820575 — J.E.T. DIALYSIS SYSTEM (May 20, 1982)
  • K772040 — TRANSDUCER PROTECTOR (November 28, 1977)