Cleared Traditional

IMX CA 125

K964185 · Abbott Diagnostics · Immunology
Nov 1997
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K964185 is an FDA 510(k) clearance for the IMX CA 125, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Abbott Diagnostics (Abbott Park, US). The FDA issued a Cleared decision on November 4, 1997, 379 days after receiving the submission on October 21, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K964185 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1996
Decision Date November 04, 1997
Days to Decision 379 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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