Cleared Traditional

K791644 - ROYCO MODEL 371 SUPER DILUTOR (FDA 510(k) Clearance)

K791644 · Royco Instruments · Hematology device

Sep 1979

Decision

27d

Days

Class 1

Risk

K791644 is an FDA 510(k) clearance for the ROYCO MODEL 371 SUPER DILUTOR. This device is classified as a Apparatus, Automated Blood Cell Diluting (Class I - General Controls, product code GKH).

Submitted by Royco Instruments (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979, 27 days after receiving the submission on August 23, 1979.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number	K791644 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 23, 1979
Decision Date	September 19, 1979
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—