ARMTROL AND FERMTROL— 510(k) K780802

Substantially Equivalent

Biotron , Ltd.

FDA 510(k) clearance K780802 for ARMTROL AND FERMTROL, Substantially Equivalent on 1978-06-13. Applicant: Biotron , Ltd.. Device class: 1.

Clearance details

Applicant: Biotron , Ltd.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1978-05-11
Decision date: 1978-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJW

K170091 — UA-Cellular Complete2017-02-09
K142262 — AUTION CHECK PLUS2015-04-10
K131444 — UA-CELLULAR COMPLETE2014-01-29
K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 22011-09-30
K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL2011-02-02

More clearances from Biotron , Ltd.

K910135 — THE UNIVERSAL CEMENT PLUG(TM)1991-03-05
K843583 — FIRM-A-TRON MARK X1984-11-29
K810634 — FIRM-A-TRON1981-06-12
K780803 — TILL-U-TEST, DIP SLIDE1978-06-06

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