KEO · Class I · 21 CFR 864.4010

FDA Product Code KEO: Formulations, Paraffin, All

Leading manufacturers include Surgipath Medical Industries, Inc., E.I. Dupont DE Nemours & Co., Inc. and Miles Laboratories, Inc..

11
Total
11
Cleared
22d
Avg days
1976
Since

FDA 510(k) Cleared Formulations, Paraffin, All Devices (Product Code KEO)

11 devices
1–11 of 11
Cleared Jun 17, 1986
MICRO THIN* PARAFFIN
K862223
Richard-Allan Medical Ind., Inc.
Pathology · 6d
Cleared Apr 11, 1986
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
K861270
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Jun 26, 1984
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K842053
Sherwood Medical Co.
Pathology · 35d
Cleared Oct 14, 1983
TECHNICON PARACUT
K833071
Technicon Instruments Corp.
Pathology · 36d
Cleared Jun 17, 1983
PARAFFIN INFILTRATION MEDIUM
K831580
Surgipath Medical Industries, Inc.
Pathology · 31d
Cleared Aug 31, 1981
VASPAR SEALENT
K812191
American Scientific Products
Microbiology · 28d
Cleared Mar 17, 1981
PARAFFIN EMBEDDING MEDIUM
K810568
Surgipath Medical Industries, Inc.
Radiology · 14d
Cleared Jan 28, 1981
HISTOLOGICAL EMBEDDING MEDIA
K803241
Miles Laboratories, Inc.
Pathology · 36d
Cleared Sep 21, 1976
SORVALL EMBEDDING MEDIUM
K760602
E.I. Dupont DE Nemours & Co., Inc.
Pathology · 14d

About Product Code KEO - Regulatory Context