MULTI-FUNCTION BLOOD GAS CONTROL— 510(k) K874408

Name: FDA 510(k) clearance K874408
Creator: U.S. Food and Drug Administration
Published: 1987-12-14

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K874408 for MULTI-FUNCTION BLOOD GAS CONTROL, Substantially Equivalent on 1987-12-14. Applicant: Bionostics, Inc.. Device class: 1.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1987-10-28
Decision date: 1987-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJS

view all

K152553 — CueSee Hypoxic2016-04-22
K150226 — Hematocrit and Metabolite QUALICHECK2015-05-13
K130415 — HIGH METABOLITE QUALICHECK2013-03-26
K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 32013-03-15
K033063 — MISSION CONTROLS2003-12-12

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.