LEECO T3-QUANT DIAG. KIT— 510(k) K834348

Name: FDA 510(k) clearance K834348
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K834348 for LEECO T3-QUANT DIAG. KIT, Substantially Equivalent on 1984-02-21. Applicant: Leeco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Leeco Diagnostics, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1983-12-13
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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

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K895765 — LEECO PREVIEW(R) EBV (EIA)1989-10-31
K894122 — LEECO VIS-DISK STREP-A (EIA)1989-08-15
K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M1989-06-16
K891096 — VIS-DISK HCG (EIA) JPL-041M1989-06-16
K883269 — PRL-QUANT1988-09-13

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.