Home / 510(k) Clearances / K984530

510(k) K984530

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE by Metrika, Inc. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1999
Date Received
December 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Metrika, Inc.

  • K051321 — INVIEW (June 13, 2005)
  • K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE (December 23, 2003)
  • K022661 — A1CNOW FOR HOME USE (December 13, 2002)
  • K020235 — A1CNOW FOR PROFESSIONAL USE (February 15, 2002)
  • K020234 — A1CNOW FOR RX HOME USE (February 15, 2002)
  • K000885 — DRX HBA1C - FOR PRESCRIPTION HOME USE (September 26, 2000)
  • K000887 — DRX HBA1C (July 26, 2000)
  • K992997 — OSTEOMARK NTX POC (November 9, 1999)
  • K991532 — DRX QT. HCG (September 17, 1999)
  • K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (July 12, 1999)

Other clearances for product code JFY

  • K252619 — QSCHECK UISACR (February 20, 2026)
  • K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3) (November 24, 2021)
  • K193649 — Yumizen C1200 Creatinine PAP (May 10, 2021)
  • K182384 — ACR LAB Urine Analysis Test System (July 26, 2019)
  • K183555 — GEM Premier ChemSTAT (February 16, 2019)
  • K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (December 10, 2018)
  • K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI (October 30, 2018)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu (December 22, 2014)