Cleared Traditional

LYNX EL MICROSCOPY TISSUE PROCESSOR

K862457 · Australian Biomedical Corporation , Ltd. · Pathology

Jul 1986

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K862457 is an FDA 510(k) clearance for the LYNX EL MICROSCOPY TISSUE PROCESSOR, a Cassettes, Tissue (Class I — General Controls, product code IDZ), submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on July 16, 1986, 16 days after receiving the submission on June 30, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number	K862457 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1986
Decision Date	July 16, 1986
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—