Cleared Traditional

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

K121533 · Tosoh Bioscience, Inc. · Chemistry
Jun 2012
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K121533 is an FDA 510(k) clearance for the ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on June 15, 2012, 22 days after receiving the submission on May 24, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K121533 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2012
Decision Date June 15, 2012
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LPS — Urinary Homocystine (nonquantitative) Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1377

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