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510(k) K051111

SENTINEL UIBC LIQUID by Sentinel Ch. Srl — Product Code JQF

K051111 is an FDA 510(k) premarket notification submitted by Sentinel Ch. Srl for the device "SENTINEL UIBC LIQUID". The FDA issued a decision of Substantially Equivalent on November 17, 2005. The device falls under product code JQF (Bathophenanthroline, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Sentinel Ch. Srl has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2005
Date Received
May 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

Other clearances by Sentinel Ch. Srl

  • K242585 — Cystatin C (May 16, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K192118 — CRP Vario (November 8, 2019)
  • K173833 — CRP Vario (September 27, 2018)
  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)

Other clearances for product code JQF

  • K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR (January 20, 1999)
  • K875176 — WAKO(TM) UIBC (February 2, 1988)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K830032 — TOTAL IRON BINDING CAPACITY TEST (January 28, 1983)
  • K811942 — J & S IRON SATURATING REAGENT (September 8, 1981)
  • K810086 — IRON & TICB (January 28, 1981)
  • K792409 — ELVI TOTAL IRON BINDING CAPACITY (December 6, 1979)

FDA data resources