Cleared Traditional

FORMALIN BUFFER CONCENTRATE

K771201 · Central Labs. Assoc. MD Pathologists · Pathology
Aug 1977
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K771201 is an FDA 510(k) clearance for the FORMALIN BUFFER CONCENTRATE, a Formaldehyde (formalin, Formol) (Class I — General Controls, product code IGG), submitted by Central Labs. Assoc. MD Pathologists (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 48 days after receiving the submission on July 5, 1977. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K771201 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1977
Decision Date August 22, 1977
Days to Decision 48 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGG — Formaldehyde (formalin, Formol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010