Cleared Traditional

K861201 - FORMALDEHYDE SOLUTION, 37% (FDA 510(k) Clearance)

K861201 · Surgipath Medical Industries, Inc. · Pathology device

Apr 1986

Decision

11d

Days

Class 1

Risk

K861201 is an FDA 510(k) clearance for the FORMALDEHYDE SOLUTION, 37%. This device is classified as a Formaldehyde (formalin, Formol) (Class I - General Controls, product code IGG).

Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on April 11, 1986, 11 days after receiving the submission on March 31, 1986.

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

Submission Details

510(k) Number	K861201 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 1986
Decision Date	April 11, 1986
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—