Cleared Traditional

IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

K000006 · Diagnostic Products Corp. · Toxicology
Feb 2000
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K000006 is an FDA 510(k) clearance for the IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 28, 2000, 56 days after receiving the submission on January 3, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K000006 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2000
Decision Date February 28, 2000
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

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