Cleared Traditional

ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

K973535 · Schiapparelli Biosystems, Inc. · Chemistry
Oct 1997
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K973535 is an FDA 510(k) clearance for the ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on October 20, 1997, 32 days after receiving the submission on September 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K973535 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1997
Decision Date October 20, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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