Cleared Traditional

SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)

K011525 · Biosafe Laboratories, Inc. · Chemistry
Jul 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K011525 is an FDA 510(k) clearance for the SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 16, 2001, 60 days after receiving the submission on May 17, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K011525 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2001
Decision Date July 16, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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