TECHNICON ASSIST POTASSIUM— 510(k) K883585

Name: FDA 510(k) clearance K883585
Creator: U.S. Food and Drug Administration
Published: 1988-11-29

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K883585 for TECHNICON ASSIST POTASSIUM, Substantially Equivalent on 1988-11-29. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1988-08-23
Decision date: 1988-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEJ

view all

K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 22005-02-10
K943026 — POTASSIUM QVET1994-12-09
K904033 — REFLOTRON POTASSIUM TEST TABS1990-11-06
K902574 — POTASSIUM REAGENT SET1990-07-10
K883586 — TECHNICON RA-100 SYSTEM POTASSIUM1988-11-29

More clearances from Technicon Instruments Corp.

view all

K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL1991-11-27
K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)1991-11-27
K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)1991-11-22
K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES1991-09-25
K912413 — CHEM-LINK DATA BASE MANAGER1991-07-01

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