Cleared Traditional

IMMUSTRIP HAMA IGG

K972873 · Immunomedics, Inc. · Immunology
Mar 1998
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K972873 is an FDA 510(k) clearance for the IMMUSTRIP HAMA IGG, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Immunomedics, Inc. (Morris Plains, US). The FDA issued a Cleared decision on March 17, 1998, 225 days after receiving the submission on August 4, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K972873 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1997
Decision Date March 17, 1998
Days to Decision 225 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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