CELL-DYN ISOTONIC DILUENT— 510(k) K881130

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K881130 for CELL-DYN ISOTONIC DILUENT, Substantially Equivalent on 1988-03-31. Applicant: Abbott Diagnostics. Device class: 1.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1988-03-16
Decision date: 1988-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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
K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT1987-09-09

More clearances from Abbott Diagnostics

K964185 — IMX CA 1251997-11-04
K972182 — ABBOTT STREP A CONTROLS1997-08-13
K961439 — ABBOTT CELL-DYN 4000 SYSTEM1996-10-18
K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER1989-04-18
K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN1988-04-21

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