Cleared Traditional

NUCLISENS CMV PP67

K983762 · Organon Teknika Corp. · Microbiology
Sep 1999
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K983762 is an FDA 510(k) clearance for the NUCLISENS CMV PP67, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on September 15, 1999, 324 days after receiving the submission on October 26, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K983762 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1998
Decision Date September 15, 1999
Days to Decision 324 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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