KYOTEST 8V— 510(k) K840828

Substantially Equivalent

Kyoto Diagnostics, Inc.

FDA 510(k) clearance K840828 for KYOTEST 8V, Substantially Equivalent on 1984-05-14. Applicant: Kyoto Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Kyoto Diagnostics, Inc.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 1984-02-24
Decision date: 1984-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kyoto Diagnostics, Inc.

K861733 — ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS1986-07-25
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

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