Cleared Traditional

K800104 - ROYCO MODEL 951 CELL MIXER (FDA 510(k) Clearance)

K800104 · Royco Instruments · Hematology device

Feb 1980

Decision

21d

Days

Class 1

Risk

K800104 is an FDA 510(k) clearance for the ROYCO MODEL 951 CELL MIXER. This device is classified as a Device, Blood Mixing And Blood Weighing (Class I - General Controls, product code KSQ).

Submitted by Royco Instruments (Mchenry, US). The FDA issued a Cleared decision on February 6, 1980, 21 days after receiving the submission on January 16, 1980.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9195.

Submission Details

510(k) Number	K800104 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 1980
Decision Date	February 06, 1980
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—