ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800— 510(k) K101831

Name: FDA 510(k) clearance K101831
Creator: U.S. Food and Drug Administration
Published: 2010-10-01

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K101831 for ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800, Substantially Equivalent on 2010-10-01. Applicant: Bionostics, Inc.. Device class: 2.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code OSL
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2010-07-01
Decision date: 2010-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devens, MA, US

Download summary PDF View on FDA.gov ↗

More clearances from Bionostics, Inc.

view all

K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC2013-05-31
K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK2013-02-14
K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER2013-01-25
K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA2012-01-30
K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT2011-12-23

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