Cleared Traditional

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS

K935568 · Baxter Diagnostics, Inc. · Toxicology
Mar 1994
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K935568 is an FDA 510(k) clearance for the PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Baxter Diagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 11, 1994, 113 days after receiving the submission on November 18, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K935568 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1993
Decision Date March 11, 1994
Days to Decision 113 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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