CIBA CORNING ACS FREE T3 IMMUNOASSAY— 510(k) K932747

Name: FDA 510(k) clearance K932747
Creator: U.S. Food and Drug Administration
Published: 1993-12-03

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K932747 for CIBA CORNING ACS FREE T3 IMMUNOASSAY, Substantially Equivalent on 1993-12-03. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1993-06-08
Decision date: 1993-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDP

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K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)2000-10-05
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10051999-06-02
K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

More clearances from Ciba Corning Diagnostics Corp.

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K962559 — ACS CORTISOL IMMUNOASSAY1996-11-05
K963251 — CIBA CORNING ACS; 180 DPD ASSAY1996-10-15
K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 41996-07-26
K961657 — CIBA CORNING 400 SYSTEM1996-06-25
K962021 — CIBA CORNING 348 SYSTEM1996-06-24

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.