DIA T1, T2 & T3— 510(k) K842286

Substantially Equivalent

Diatech, Inc.

FDA 510(k) clearance K842286 for DIA T1, T2 & T3, Substantially Equivalent on 1984-09-11. Applicant: Diatech, Inc.. Device class: 2.

Clearance details

Applicant: Diatech, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-06-13
Decision date: 1984-09-11
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

More clearances from Diatech, Inc.

K881685 — FIBRINOGENTEST-O1988-08-09
K854938 — COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.1986-03-12
K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT1986-01-06
K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT1986-01-06
K841365 — DIA REPTIN1984-06-01

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