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510(k) K041619

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 by Biocheck, Inc. — Product Code MMI

K041619 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Biocheck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
June 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Biocheck, Inc.

  • K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (June 16, 2004)
  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (January 8, 2002)
  • K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL (July 20, 2001)
  • K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (October 2, 2000)
  • K001022 — BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (September 26, 2000)
  • K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025 (September 24, 1999)
  • K992528 — BIOCHECK IGE ELISA, MODEL BC-1035 (September 21, 1999)
  • K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (July 22, 1999)
  • K991146 — TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (June 22, 1999)

Other clearances for product code MMI

  • K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System (June 11, 2026)
  • K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (October 29, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K242870 — Access hsTnI (June 16, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)
  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
  • K222881 — Access hsTnI (December 18, 2023)
  • K230648 — Access hsTnI (December 4, 2023)
  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)

FDA data resources