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510(k) K890423

V-TREND TARGET CRP TEST by Texas Immunology, Inc. — Product Code DCK

K890423 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND TARGET CRP TEST". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
January 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
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)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (July 23, 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)
  • K890041 — V-TREND TARGET IM TEST (January 23, 1989)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)

FDA data resources