CHIRON DIAGNOSTICS ACS: 180 FT3— 510(k) K991692

Name: FDA 510(k) clearance K991692
Creator: U.S. Food and Drug Administration
Published: 1999-06-18

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K991692 for CHIRON DIAGNOSTICS ACS: 180 FT3, Substantially Equivalent on 1999-06-18. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1999-05-18
Decision date: 1999-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, 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
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
K983434 — ABBOTT ARCHITECT TOTAL T31998-11-20

More clearances from Chiron Diagnostics Corp.

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K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY1999-08-05
K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE1999-06-30
K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY1998-10-15
K981478 — ACS:CENTAUR CEA1998-08-12
K981839 — ACS:CENTAUR PSA2 IMMUNOASSAY1998-08-12

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.