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

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..

Clearance details

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

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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.