HYCEL ROTOR-MIXER AND/OR MULTI— 510(k) K842746

Name: FDA 510(k) clearance K842746
Creator: U.S. Food and Drug Administration
Published: 1984-08-17

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K842746 for HYCEL ROTOR-MIXER AND/OR MULTI, Substantially Equivalent on 1984-08-17. Applicant: R&D Systems, Inc.. Device class: 1.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code KSQ
Device class: Class 1
Regulation: 21 CFR 864.9195
Advisory panel: Hematology
Date received: 1984-07-13
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSQ

view all

K820712 — SEPCOR UNIT COLLECTION MONITOR1982-05-07
K812533 — PLATELET AGITATOR1981-09-29
K810617 — MOBILE MATIC AUTOMATIC DONOR SCALE1981-04-07
K802608 — HEMATIC BLOOD MIXER1980-12-11
K800104 — ROYCO MODEL 951 CELL MIXER1980-02-06

More clearances from R&D Systems, Inc.

view all

K160606 — BC-5D Hematology Control2016-09-01
K130962 — R&D 5D RETIC HEMATOLOGY CONTROL2013-07-24
K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2011-04-28
K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL2010-01-29
K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2009-10-28

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