CELL-DYN BRAND HEMATOLOGY REAGENTS— 510(k) K852372

Name: FDA 510(k) clearance K852372
Creator: U.S. Food and Drug Administration
Published: 1985-09-03

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K852372 for CELL-DYN BRAND HEMATOLOGY REAGENTS, Substantially Equivalent on 1985-09-03. Applicant: Abbott Diagnostics. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1985-06-04
Decision date: 1985-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

view all

K160586 — XN-L CHECK2016-12-22
K160588 — XN CHECK BF2016-12-22
K160590 — XN CHECK2016-12-22
K160606 — BC-5D Hematology Control2016-09-01
K141957 — XN CHECK BF2014-12-05

More clearances from Abbott Diagnostics

view all

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.