Cleared Traditional

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

K033234 · Diagnostic Products Corp. · Chemistry
Dec 2003
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K033234 is an FDA 510(k) clearance for the IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 12, 2003, 67 days after receiving the submission on October 6, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K033234 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2003
Decision Date December 12, 2003
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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