LDZ · Class I · 21 CFR 864.4010

FDA Product Code LDZ: Fixative, Alcohol Containing

Leading manufacturers include Alpha-Tec Systems, Inc., E K Ind., Inc. and Accra Laboratories, Inc..

8
Total
8
Cleared
79d
Avg days
1978
Since

FDA 510(k) Cleared Fixative, Alcohol Containing Devices (Product Code LDZ)

8 devices
1–8 of 8
Cleared Aug 17, 1988
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
K883048
Alpha-Tec Systems, Inc.
Pathology · 32d
Cleared May 25, 1988
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
K881922
Surgipath Medical Industries, Inc.
Pathology · 16d
Cleared May 13, 1988
ATS PVA FIXATIVE SOLUTION
K881698
Alpha-Tec Systems, Inc.
Pathology · 24d
Cleared Aug 01, 1986
SACCOMANNO SPECIMAN SOLUTION
K862725
Mill-Rose Laboratory
Pathology · 15d
Cleared Sep 27, 1984
BIOFIX
K843428
Accra Laboratories, Inc.
Pathology · 23d
Cleared Sep 07, 1984
WRIGHT STAIN FIXATIVE
K842913
E K Ind., Inc.
Pathology · 44d
Cleared Jun 08, 1983
PVA FIXATIVE/FORMALIN
K831061
American Micro Scan
Pathology · 68d
Cleared Jan 06, 1978
FA TISSUE FIXATIVE & WASH SET
K761138
Zeus Scientific, Inc.
Pathology · 406d

About Product Code LDZ - Regulatory Context