Cleared Traditional

UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

K981573 · United Biotech, Inc. · Chemistry
Sep 1998
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K981573 is an FDA 510(k) clearance for the UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 15, 1998, 134 days after receiving the submission on May 4, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K981573 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1998
Decision Date September 15, 1998
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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