LED · Class I · 21 CFR 864.1850

FDA Product Code LED: Stains, Chemical Solution

Leading manufacturers include Sigma Chemical Co., E K Ind., Inc. and Difco Laboratories, Inc..

16
Total
16
Cleared
32d
Avg days
1981
Since

FDA 510(k) Cleared Stains, Chemical Solution Devices (Product Code LED)

16 devices
1–16 of 16
Cleared Mar 12, 1986
SPOTTEST CALCOFLUOR WHITE REAGENT
K860795
Difco Laboratories, Inc.
Pathology · 8d
Cleared Apr 29, 1985
SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR
K851481
Difco Laboratories, Inc.
Pathology · 14d
Cleared Sep 11, 1984
GOMORI'S TRICHROME STAIN
K842930
E K Ind., Inc.
Pathology · 48d
Cleared Aug 03, 1984
SUPERMOUNT
K842727
E K Ind., Inc.
Pathology · 21d
Cleared Oct 31, 1983
TRICHROME STAIN LG SOLUTION
K833167
Sigma Chemical Co.
Hematology · 45d
Cleared Oct 31, 1983
IRON STAIN PROCEDURE HT20
K833388
Sigma Chemical Co.
Pathology · 33d

About Product Code LED - Regulatory Context