Cleared Traditional

IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

K000257 · Diagnostic Products Corp. · Immunology
Feb 2000
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K000257 is an FDA 510(k) clearance for the IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 23, 2000, 27 days after receiving the submission on January 27, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K000257 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2000
Decision Date February 23, 2000
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JFH — Acid Phosphatase (prostatic), Tartrate Inhibited
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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