ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER— 510(k) K780946

Name: FDA 510(k) clearance K780946
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K780946 for ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER, Substantially Equivalent on 1978-07-27. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code JPJ
Device class: Class 2
Regulation: 21 CFR 864.5300
Advisory panel: Hematology
Date received: 1978-06-09
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPJ

view all

K904675 — QBC SYSTEM MCHC1990-11-02
K761304 — JTB 700 HEMATOLOGY ANALYZER1977-02-01

More clearances from Hycel, Inc.

view all

K802422 — HYCEL TRIGYCERIDE II TEST1980-10-06
K790335 — HYCEL M1979-02-27
K782116 — KETOSTEROID TEST, HYCEL-171979-01-26
K782176 — HYCEL LDH-INT TEST1979-01-26
K782100 — HYCEL COUNTER 3331979-01-03

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