E-CHECK (XE)— 510(k) K063218

Substantially Equivalent

Streck

FDA 510(k) clearance K063218 for E-CHECK (XE), Substantially Equivalent on 2006-12-14. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2006-10-24
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

K160586 — XN-L CHECK2016-12-22
K160588 — XN CHECK BF2016-12-22
K160590 — XN CHECK2016-12-22
K160606 — BC-5D Hematology Control2016-09-01
K141957 — XN CHECK BF2014-12-05

More clearances from Streck

K254166 — MDx-Chex for BCN2026-03-23
K231221 — MDx-Chex for BC-GP2023-07-27
K231223 — MDx-Chex for BC-GN2023-07-27
K170091 — UA-Cellular Complete2017-02-09
K160585 — XN CAL2016-12-22

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