REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)— 510(k) K001607

Name: FDA 510(k) clearance K001607
Creator: U.S. Food and Drug Administration
Published: 2000-10-05

Substantially Equivalent

Repromedix Corp.

FDA 510(k) clearance K001607 for REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104), Substantially Equivalent on 2000-10-05. Applicant: Repromedix Corp.. Device class: 2.

Clearance details

Applicant: Repromedix Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 2000-05-24
Decision date: 2000-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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K981824 — OPTICOAT T3 EIA KIT1998-12-22
K983434 — ABBOTT ARCHITECT TOTAL T31998-11-20

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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.