FIBRINOGEN TEST— 510(k) K834571

Substantially Equivalent

Diatech, Inc.

FDA 510(k) clearance K834571 for FIBRINOGEN TEST, Substantially Equivalent on 1984-02-04. Applicant: Diatech, Inc.. Device class: 2.

Clearance details

Applicant: Diatech, Inc.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1983-12-29
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQJ

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K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)1997-10-09
K970189 — FIF TM1997-05-21

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
K842286 — DIA T1, T2 & T31984-09-11

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