TDS Standard Solution— 510(k) K191496

Substantially Equivalent

Mesa Laboratories, Inc.

FDA 510(k) clearance K191496 for TDS Standard Solution, Substantially Equivalent on 2019-08-05. Applicant: Mesa Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Mesa Laboratories, Inc.
Product code: Code FKH
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2019-06-05
Decision date: 2019-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKH

K130100 — COMINED STANDARD SOLUTION2013-04-18
K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION2004-07-02
K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION2004-02-27
K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE2003-09-17
K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.1986-10-24

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K122362 — SMART-WELL INCUBATOR2013-03-26
K112018 — SMART READ EZTEST STEAM2012-01-30

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