Cleared Traditional

IMMULITE PAP

K931701 · Diagnostic Products Corp. · Chemistry
Jan 1994
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K931701 is an FDA 510(k) clearance for the IMMULITE PAP, 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 January 27, 1994, 296 days after receiving the submission on April 6, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K931701 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1993
Decision Date January 27, 1994
Days to Decision 296 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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