Cleared Special

EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

K011528 · Syva Co. · Chemistry
Jun 2001
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K011528 is an FDA 510(k) clearance for the EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 6, 2001, 20 days after receiving the submission on May 17, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K011528 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2001
Decision Date June 06, 2001
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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