Cleared Traditional

TISSUE-TEK III MICROJECT DISP. BLADE SYS

K801426 · Miles Laboratories, Inc. · Pathology

Jul 1980

Decision

41d

Days

Class 1

Risk

About This 510(k) Submission

K801426 is an FDA 510(k) clearance for the TISSUE-TEK III MICROJECT DISP. BLADE SYS, a Microtome, Accessories (Class I — General Controls, product code IDL), submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 41 days after receiving the submission on June 17, 1980. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number	K801426 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 1980
Decision Date	July 28, 1980
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—