Panels › Hematology › Product code LED · Class 1
Stains, Chemical Solution
Regulation 864.1850
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LED
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytocolor, Inc. | 5 | 0 |
| Difco Laboratories, Inc. | 2 | 0 |
| E K Ind., Inc. | 2 | 0 |
| Sigma Chemical Co. | 2 | 0 |
| American Scientific Products | 1 | 0 |
| Devetec, Inc. | 1 | 0 |
| Preventive Diagnostics Corp. | 1 | 0 |
| Scandinavian Formulas, Inc. | 1 | 0 |
| Sinclair Pharmaceuticals, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2005 | K051409 | SLIVASURE Scandinavian Formulas, Inc. | LED |
| Dec 2, 2002 | K023046 | SST SALIVA SUPPORTING TABLETS Sinclair Pharmaceuticals, Ltd., GB | LED |
| Mar 12, 1986 | K860795 | SPOTTEST CALCOFLUOR WHITE REAGENT Difco Laboratories, Inc. | LED |
| Feb 20, 1986 | K860321 | LYSOCOLOR Cytocolor, Inc. | LED |
| Feb 20, 1986 | K860320 | GRANULOCOLOR Cytocolor, Inc. | LED |
| Feb 20, 1986 | K860319 | MEGACOLOR Cytocolor, Inc. | LED |
| Feb 20, 1986 | K860317 | NEUTROCOLOR Cytocolor, Inc. | LED |
| Feb 20, 1986 | K860316 | PANOPTIKON Cytocolor, Inc. | LED |
| Oct 31, 1985 | K854176 | POLYCHROME IV STAIN Devetec, Inc. | LED |
| Apr 29, 1985 | K851481 | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR Difco Laboratories, Inc. | LED |
| Sep 11, 1984 | K842930 | GOMORI'S TRICHROME STAIN E K Ind., Inc. | LED |
| Aug 3, 1984 | K842727 | SUPERMOUNT E K Ind., Inc. | LED |
| Feb 10, 1984 | K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 Preventive Diagnostics Corp. | LED |
| Oct 31, 1983 | K833388 | IRON STAIN PROCEDURE HT20 Sigma Chemical Co. | LED |
| Oct 31, 1983 | K833167 | TRICHROME STAIN LG SOLUTION Sigma Chemical Co. | LED |
| Aug 31, 1981 | K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID American Scientific Products | LED |
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