Cleared Traditional

DRY-FORM

K872663 · Anatech, Ltd. · Pathology
Aug 1987
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K872663 is an FDA 510(k) clearance for the DRY-FORM, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on August 6, 1987, 29 days after receiving the submission on July 8, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K872663 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1987
Decision Date August 06, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IFP — Formalin, Neutral Buffered
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010