CREATININE (ENZYMATIC)— 510(k) K070824

Name: FDA 510(k) clearance K070824
Creator: U.S. Food and Drug Administration
Published: 2007-12-03

Substantially Equivalent

Thermofisher Scientific OY

FDA 510(k) clearance K070824 for CREATININE (ENZYMATIC), Substantially Equivalent on 2007-12-03. Applicant: Thermofisher Scientific OY. Device class: 2.

Clearance details

Applicant: Thermofisher Scientific OY
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2007-03-26
Decision date: 2007-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFY

view all

K252619 — QSCHECK UISACR2026-02-20
K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)2021-11-24
K193649 — Yumizen C1200 Creatinine PAP2021-05-10
K182384 — ACR LAB Urine Analysis Test System2019-07-26
K183555 — GEM Premier ChemSTAT2019-02-16

More clearances from Thermofisher Scientific OY

view all

K110035 — INDIKO2011-06-28
K073295 — UREA/BUN, SCAL, NORTROL, ABTROL2008-05-29
K073612 — URIC ACID (AOX), SCAL, NORTROL, ABTROL2008-05-23
K073191 — ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL2008-02-28
K073355 — CALCIUM, SCAL, NORTROL, ABTROL2008-02-28

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