FETALTROL— 510(k) K002511

Substantially Equivalent

Trillium Diagnostics, LLC

FDA 510(k) clearance K002511 for FETALTROL, Substantially Equivalent on 2000-09-11. Applicant: Trillium Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Trillium Diagnostics, LLC
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2000-08-15
Decision date: 2000-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

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

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