Cleared Traditional

K832451 - CLEAR-RITE 3
(FDA 510(k) Clearance)

K832451 · Richard-Allan Medical Ind., Inc. · Pathology device

Aug 1983

Decision

18d

Days

Class 1

Risk

K832451 is an FDA 510(k) clearance for the CLEAR-RITE 3. This device is classified as a Agent, Clearing (Class I - General Controls, product code KEM).

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 18 days after receiving the submission on July 25, 1983.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K832451 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 25, 1983
Decision Date	August 12, 1983
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—