FDA Product Code
FDA Product Code LED — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051409 | SLIVASURE | Scandinavian Formulas, Inc. | 2005-08-08 | Traditional | PDF ↗ |
| K023046 | SST SALIVA SUPPORTING TABLETS | Sinclair Pharmaceuticals, Ltd. | 2002-12-02 | Traditional | PDF ↗ |
| K860795 | SPOTTEST CALCOFLUOR WHITE REAGENT | Difco Laboratories, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K860320 | GRANULOCOLOR | Cytocolor, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K860317 | NEUTROCOLOR | Cytocolor, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K860316 | PANOPTIKON | Cytocolor, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K860319 | MEGACOLOR | Cytocolor, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K860321 | LYSOCOLOR | Cytocolor, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K854176 | POLYCHROME IV STAIN | Devetec, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K851481 | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR | Difco Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K842930 | GOMORI'S TRICHROME STAIN | E K Ind., Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K842727 | SUPERMOUNT | E K Ind., Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 | Preventive Diagnostics Corp. | 1984-02-10 | Traditional | PDF ↗ |
| K833167 | TRICHROME STAIN LG SOLUTION | Sigma Chemical Co. | 1983-10-31 | Traditional | PDF ↗ |
| K833388 | IRON STAIN PROCEDURE HT20 | Sigma Chemical Co. | 1983-10-31 | Traditional | PDF ↗ |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | American Scientific Products | 1981-08-31 | Traditional | PDF ↗ |
Product code LED · Class I · Hematology. Data: openFDA.