THROMBONOSTIKA F1.2— 510(k) K911434

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K911434 for THROMBONOSTIKA F1.2, Substantially Equivalent on 1991-10-31. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code MIF
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1991-04-02
Decision date: 1991-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIF

K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT2004-12-10
K964934 — THROMBONOSTIKA F1.21997-03-18
K962176 — TPP1996-10-18
K922934 — ENZYGNOST F 1+21992-11-16
K920895 — DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA1992-06-04

More clearances from Organon Teknika Corp.

K003104 — BACT/ALERT CSR2000-10-20
K000492 — MDA D-DIMER2000-06-07
K000378 — BACT/ALERT MB CULTURE BOTTLE2000-03-02
K994343 — BACT/ALERT SV2000-02-10
K993423 — BACT/ALERT SA1999-12-15

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