Cleared Traditional

N/T PROTEIN CONTROL SY/L, M AND H

K952593 · Behring Diagnostics, Inc. · Immunology
Jul 1995
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K952593 is an FDA 510(k) clearance for the N/T PROTEIN CONTROL SY/L, M AND H, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 17, 1995, 41 days after receiving the submission on June 6, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number K952593 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1995
Decision Date July 17, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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