THROMBO-TEST (X)— 510(k) K801054

Substantially Equivalent

Medtro GmbH

FDA 510(k) clearance K801054 for THROMBO-TEST (X), Substantially Equivalent on 1981-03-13. Applicant: Medtro GmbH. Device class: 2.

Clearance details

Applicant: Medtro GmbH
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-05-05
Decision date: 1981-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.