Cleared Traditional

K881174 - RID PLATE READER (FDA 510(k) Clearance)

Jun 1988
Decision
82d
Days
Class 1
Risk

K881174 is an FDA 510(k) clearance for the RID PLATE READER. This device is classified as a Plates And Equipment, Radial Immunodiffusion (Class I - General Controls, product code JZQ).

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on June 8, 1988, 82 days after receiving the submission on March 18, 1988.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4800.

Submission Details

510(k) Number K881174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date June 08, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary

Device Classification

Product Code JZQ — Plates And Equipment, Radial Immunodiffusion
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.4800