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510(k) K910108

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED by Gds Diagnostics — Product Code JIN

K910108 is an FDA 510(k) premarket notification submitted by Gds Diagnostics for the device "GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED". The FDA issued a decision of Substantially Equivalent on March 4, 1991. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Gds Diagnostics has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1991
Date Received
January 10, 1991
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 Gds Diagnostics

  • K931257 — ACETASITE (July 8, 1993)
  • K910881 — CONTROL AND LINEARITY (September 13, 1991)
  • K891761 — GDS ENZYMATIC THEOPHYLLINE REAGENT (May 16, 1989)

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)

FDA data resources