CELL-CHEX WITH CPPD CRYSTALS— 510(k) K110718

Substantially Equivalent

Streck

FDA 510(k) clearance K110718 for CELL-CHEX WITH CPPD CRYSTALS, Substantially Equivalent on 2011-05-26. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code GLQ
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2011-03-15
Decision date: 2011-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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K994388 — XE CHECK2000-01-14

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K160585 — XN CAL2016-12-22

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