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

Substantially Equivalent

Repromedix Corp.

Clearance details

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

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.