ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS— 510(k) K861733

Name: FDA 510(k) clearance K861733
Creator: U.S. Food and Drug Administration
Published: 1986-07-25

Substantially Equivalent

Kyoto Diagnostics, Inc.

FDA 510(k) clearance K861733 for ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS, Substantially Equivalent on 1986-07-25. Applicant: Kyoto Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Kyoto Diagnostics, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1986-05-06
Decision date: 1986-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

view all

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

More clearances from Kyoto Diagnostics, Inc.

view all

K843003 — GLUCOSE AUTO& STAT GA-11201984-09-28
K842750 — OSMOTIC PRESSURE AUTO & STAT OM-60101984-08-17
K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM1984-07-16
K841713 — KYOTEST UG URINE TEST REAGENT STRIP1984-05-31
K841714 — KYOTEST 2V, URINE TEST REAGENT STRIP1984-05-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.