DELFIA(TM) TRIIODOTHYRONINE (T3) KIT— 510(k) K864452

Name: FDA 510(k) clearance K864452
Creator: U.S. Food and Drug Administration
Published: 1987-02-02

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K864452 for DELFIA(TM) TRIIODOTHYRONINE (T3) KIT, Substantially Equivalent on 1987-02-02. Applicant: Lkb Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1986-11-12
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

More clearances from Lkb Instruments, Inc.

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K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER1987-11-04
K872955 — DELFIA(TM) FERRITIN KIT1987-08-21
K871303 — DELFIA(TM) THYROXINE (T4) KIT1987-06-17
K871599 — DELFIA(TM) HIGE KIT1987-06-12
K871644 — DELFIA (TM) HTSH KIT1987-05-12

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.