ROYCO MODEL 371 SUPER DILUTOR— 510(k) K791644

Name: FDA 510(k) clearance K791644
Creator: U.S. Food and Drug Administration
Published: 1979-09-19

Substantially Equivalent

Royco Instruments

FDA 510(k) clearance K791644 for ROYCO MODEL 371 SUPER DILUTOR, Substantially Equivalent on 1979-09-19. Applicant: Royco Instruments. Device class: 1.

Clearance details

Applicant: Royco Instruments
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 1979-08-23
Decision date: 1979-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKH

view all

K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:95412010-08-26
K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM2004-03-12
K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 95182002-09-30
K021150 — COULTER CELLPREP2002-06-11
K935953 — COULTER MULTI Q PREP1994-03-11

More clearances from Royco Instruments

view all

K800104 — ROYCO MODEL 951 CELL MIXER1980-02-06
K791867 — ROYCO MODEL 921 CELL COUNTER1979-11-05
K790442 — ISOTONIC DILUENT1979-04-04

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