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510(k) K972094

TARGET CARDIAC TROPONIN I TEST by Texas Immunology, Inc. — Product Code MMI

K972094 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "TARGET CARDIAC TROPONIN I TEST". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1997
Date Received
June 4, 1997
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 Texas Immunology, Inc.

  • K991465 — DRUG STOP (December 10, 1999)
  • K980153 — DRUG CHECK (March 27, 1998)
  • K973208 — FIRST SIGN (October 20, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (February 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (July 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (October 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (April 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (February 17, 1989)
  • K890041 — V-TREND TARGET IM TEST (January 23, 1989)

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