Cleared Traditional

ACE T UPTAKE REAGENT TU CALIBRATORS

K981375 · Schiapparelli Biosystems, Inc. · Chemistry
Jun 1998
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K981375 is an FDA 510(k) clearance for the ACE T UPTAKE REAGENT TU CALIBRATORS, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on June 10, 1998, 55 days after receiving the submission on April 16, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K981375 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1998
Decision Date June 10, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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