Cleared Traditional

ACE CEDIA PHENOBARBITAL ASSAY

K942501 · Schiapparelli Biosystems, Inc. · Chemistry
Oct 1994
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K942501 is an FDA 510(k) clearance for the ACE CEDIA PHENOBARBITAL ASSAY, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on October 6, 1994, 135 days after receiving the submission on May 24, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K942501 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1994
Decision Date October 06, 1994
Days to Decision 135 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DLZ — Enzyme Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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