COBAS(R) CORE FT4 EIA— 510(k) K932607

Name: FDA 510(k) clearance K932607
Creator: U.S. Food and Drug Administration
Published: 1994-01-24

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K932607 for COBAS(R) CORE FT4 EIA, Substantially Equivalent on 1994-01-24. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1993-05-28
Decision date: 1994-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEC

view all

K240273 — Access Free T42024-03-06
K220456 — Elecsys FT4 IV2023-04-07
K182423 — MAGLUMI 2000 FT42018-10-04
K181233 — Elecsys FT4 III2018-09-18
K173122 — Abbott Architect Free T42017-10-27

More clearances from Roche Diagnostic Systems, Inc.

view all

K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES1999-05-03
K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES1999-02-11
K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE1999-02-10
K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS1998-12-15
K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS1998-12-15

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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