REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)— 510(k) K001606

Substantially Equivalent

Repromedix Corp.

FDA 510(k) clearance K001606 for REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107), Substantially Equivalent on 2000-10-05. Applicant: Repromedix Corp..

Clearance details

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

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.