OPUS FT4 TEST SYSTEM— 510(k) K940507

Name: FDA 510(k) clearance K940507
Creator: U.S. Food and Drug Administration
Published: 1994-07-28

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K940507 for OPUS FT4 TEST SYSTEM, Substantially Equivalent on 1994-07-28. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1994-02-02
Decision date: 1994-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, 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 Pb Diagnostic Systems, Inc.

view all

K934762 — OPUS PROCAINAMIDE TEST SYSTEM1994-07-20
K933389 — OPUS CMV-G1994-06-28
K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION1994-03-07
K935229 — OPUS DIGITOXIN1993-12-22
K934705 — OPUS NAPA1993-11-22

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.