Cleared Traditional

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

K921745 · Hybritech, Inc. · Chemistry
Jul 1992
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K921745 is an FDA 510(k) clearance for the HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 1992, 108 days after receiving the submission on April 13, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K921745 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1992
Decision Date July 30, 1992
Days to Decision 108 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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