Cleared Traditional

REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

K001606 · Repromedix Corp. · Chemistry
Oct 2000
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K001606 is an FDA 510(k) clearance for the REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Repromedix Corp. (Woburn, US). The FDA issued a Cleared decision on October 5, 2000, 134 days after receiving the submission on May 24, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K001606 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2000
Decision Date October 05, 2000
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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