IGG · Class I · 21 CFR 864.4010

FDA Product Code IGG: Formaldehyde (formalin, Formol)

Leading manufacturers include Meridian Diagnostics, Inc., Central Labs. Assoc. MD Pathologists and Richard-Allan Medical Ind., Inc..

7
Total
7
Cleared
27d
Avg days
1977
Since

FDA 510(k) Cleared Formaldehyde (formalin, Formol) Devices (Product Code IGG)

7 devices
1–7 of 7
Cleared Jun 15, 1988
ZINC FORMALIN CONCENTRATE
K882268
Anatech, Ltd.
Pathology · 15d
Cleared Apr 11, 1986
FORMALDEHYDE SOLUTION, 37%
K861201
Surgipath Medical Industries, Inc.
Pathology · 11d
Cleared Jul 28, 1981
37% FORMALDEHYDE
K811794
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Nov 12, 1980
PLEASCENT OR FORMA-SCENT
K802506
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 21, 1980
PARA-PAK FORMALIN
K792705
Meridian Diagnostics, Inc.
Pathology · 25d
Cleared Jan 21, 1980
PARA-PAK SAF
K792707
Meridian Diagnostics, Inc.
Pathology · 25d
Cleared Aug 22, 1977
FORMALIN BUFFER CONCENTRATE
K771201
Central Labs. Assoc. MD Pathologists
Pathology · 48d

About Product Code IGG - Regulatory Context