CELL-DYN 22 PLUS CONTROL— 510(k) K111211

Substantially Equivalent

Streck

FDA 510(k) clearance K111211 for CELL-DYN 22 PLUS CONTROL, Substantially Equivalent on 2011-12-22. 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: 2011-04-29
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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K090137 — STAK-CHEX PLUS RETICS2009-03-18
K000945 — PARA 12 PLUS RETICS2000-04-18
K994388 — XE CHECK2000-01-14

More clearances from Streck

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K170091 — UA-Cellular Complete2017-02-09
K160585 — XN CAL2016-12-22

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