Cleared Traditional

OPUS BONE ALP

K964764 · Behring Diagnostics, Inc. · Chemistry
Jan 1997
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K964764 is an FDA 510(k) clearance for the OPUS BONE ALP, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on January 24, 1997, 58 days after receiving the submission on November 27, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K964764 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1996
Decision Date January 24, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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