Cleared Traditional

IL TEST(TM) HAPTOGLOBIN (HPT)

K915829 · Instrumentation Laboratory CO · Immunology
Jul 1992
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K915829 is an FDA 510(k) clearance for the IL TEST(TM) HAPTOGLOBIN (HPT), a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1992, 212 days after receiving the submission on December 30, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number K915829 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1991
Decision Date July 29, 1992
Days to Decision 212 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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