REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)— 510(k) K001603

Name: FDA 510(k) clearance K001603
Creator: U.S. Food and Drug Administration
Published: 2000-10-05

Substantially Equivalent

Repromedix Corp.

FDA 510(k) clearance K001603 for REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105), Substantially Equivalent on 2000-10-05. Applicant: Repromedix Corp.. Device class: 2.

Clearance details

Applicant: Repromedix Corp.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
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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