Cleared Traditional

IMX PAP

K925377 · Abbott Laboratories · Chemistry
Jan 1993
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K925377 is an FDA 510(k) clearance for the IMX PAP, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 13, 1993, 82 days after receiving the submission on October 23, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K925377 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1992
Decision Date January 13, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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