Cleared Traditional

K940768 - AD PERFECT
(FDA 510(k) Clearance)

K940768 · Chimera Research & Chemical, Inc. · Pathology device
Feb 1995
Decision
364d
Days
Class 1
Risk

K940768 is an FDA 510(k) clearance for the AD PERFECT. This device is classified as a Glutaraldehyde (Class I - General Controls, product code IFT).

Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on February 17, 1995, 364 days after receiving the submission on February 18, 1994.

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

Submission Details

510(k) Number K940768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date February 17, 1995
Days to Decision 364 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code IFT — Glutaraldehyde
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.4010