Cleared Traditional

REUMA TEST

K873782 · Sclavo, Inc. · Immunology
Nov 1987
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K873782 is an FDA 510(k) clearance for the REUMA TEST, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on November 27, 1987, 72 days after receiving the submission on September 16, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K873782 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1987
Decision Date November 27, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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