Cleared Traditional

K780946 - ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
(FDA 510(k) Clearance)

K780946 · Hycel, Inc. · Hematology
Jul 1978
Decision
48d
Days
Class 2
Risk

K780946 is an FDA 510(k) clearance for the ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER, a Red-cell Indices, Calculated (Class II — Special Controls, product code JPJ), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 48 days after receiving the submission on June 9, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5300.

Submission Details

510(k) Number K780946 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1978
Decision Date July 27, 1978
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPJ — Red-cell Indices, Calculated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5300