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510(k) K102706

CKMB UDR ASSAY by SENTINEL CH. SpA — Product Code JHS

K102706 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "CKMB UDR ASSAY". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
September 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by SENTINEL CH. SpA

  • 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)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)
  • K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY (June 19, 2008)

Other clearances for product code JHS

  • K160570 — Creatine Kinase (May 25, 2016)
  • K082226 — S40 CREATINE KINASE (CK) (September 18, 2008)
  • K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (August 21, 2006)
  • K990434 — CARESIDE CKMB (April 19, 1999)
  • K990439 — CARESIDE CK (April 19, 1999)
  • K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (June 10, 1998)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME (July 17, 1995)
  • K945083 — ACCESS CK-MB REAGENTS (November 21, 1994)
  • K943024 — KINASE ISOENZYME (August 2, 1994)

FDA data resources