XN CAL PF— 510(k) K141955

Substantially Equivalent

Streck

FDA 510(k) clearance K141955 for XN CAL PF, Substantially Equivalent on 2014-12-05. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code KRX
Device class: Class 2
Regulation: 21 CFR 864.8150
Advisory panel: Hematology
Date received: 2014-07-18
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRX

K160585 — XN CAL2016-12-22
K141962 — XN CAL2014-12-05
K120747 — XN CAL PF2012-10-22
K120745 — XN CAL2012-10-19
K111204 — CELL-DYN 22 PLUS CALIBRATOR2011-12-22

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
K160586 — XN-L CHECK2016-12-22

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