EASYRA UREA NITROGEN AND CREATININE REAGENTS— 510(k) K110675

Name: FDA 510(k) clearance K110675
Creator: U.S. Food and Drug Administration
Published: 2011-04-21

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K110675 for EASYRA UREA NITROGEN AND CREATININE REAGENTS, Substantially Equivalent on 2011-04-21. Applicant: Medica Corp.. Device class: 2.

Clearance details

Applicant: Medica Corp.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2011-03-10
Decision date: 2011-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDQ

view all

K203771 — Urea Nitrogen22022-05-31
K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER2014-09-02
K073295 — UREA/BUN, SCAL, NORTROL, ABTROL2008-05-29
K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP2007-10-12
K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM2006-03-27

More clearances from Medica Corp.

view all

K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT2013-03-01
K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL2012-05-14
K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL2011-12-06
K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL2011-11-15
K112788 — EASTLYTE NA/K/CA/PH2011-10-20

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