Cleared Traditional

DIFFERENTIAL I.M. SCREENING TEST

K873297 · Sclavo, Inc. · Immunology
Dec 1987
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K873297 is an FDA 510(k) clearance for the DIFFERENTIAL I.M. SCREENING TEST, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 14, 1987, 118 days after receiving the submission on August 18, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K873297 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1987
Decision Date December 14, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KTN — System, Test, Infectious Mononucleosis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5640

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