ISOTONIC DILUENT— 510(k) K790442

Substantially Equivalent

Royco Instruments

FDA 510(k) clearance K790442 for ISOTONIC DILUENT, Substantially Equivalent on 1979-04-04. Applicant: Royco Instruments. Device class: 1.

Clearance details

Applicant: Royco Instruments
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1979-03-07
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIF

K883989 — KVM ISOTONIC FLUSH SOLUTION1988-10-12
K883990 — KVM ISOTONIC DILUENT1988-10-12
K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT1988-07-25
K882267 — SYSMEX QUICKLYSER-II (QLS-200A)1988-07-12
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

More clearances from Royco Instruments

K800104 — ROYCO MODEL 951 CELL MIXER1980-02-06
K791867 — ROYCO MODEL 921 CELL COUNTER1979-11-05
K791644 — ROYCO MODEL 371 SUPER DILUTOR1979-09-19

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