Cleared Traditional

IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

K000012 · Diagnostic Products Corp. · Toxicology
Mar 2000
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K000012 is an FDA 510(k) clearance for the IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 3, 2000, 60 days after receiving the submission on January 3, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K000012 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2000
Decision Date March 03, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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