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510(k) K903365

KETOREX SANWA STANDARDS by Ihara Medics U.S., Inc. — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1990
Date Received
July 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
Review Panel
CH
Submission Type

Other clearances by Ihara Medics U.S., Inc.

  • K953452 — KETOREX C SANWA (May 2, 1996)
  • K912373 — KETO-340 II (July 1, 1991)
  • K903367 — KETONE TEST A SANWA STANDARD (November 20, 1990)
  • K903366 — KETONE TEST B SANWA STANDARD (November 20, 1990)

Other clearances for product code JIN

  • K201551 — KetoSens BT Blood B-Ketone Monitoring System (September 9, 2020)
  • K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System (June 5, 2020)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (May 4, 2018)
  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (April 21, 2006)
  • K033114 — KETOCHECKS (April 26, 2004)
  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)