Product code LED
- Device name
- Stains, Chemical Solution
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051409 | SLIVASURE | Scandinavian Formulas, Inc. | 2005-08-08 |
| K023046 | SST SALIVA SUPPORTING TABLETS | Sinclair Pharmaceuticals, Ltd. | 2002-12-02 |
| K860795 | SPOTTEST CALCOFLUOR WHITE REAGENT | Difco Laboratories, Inc. | 1986-03-12 |
| K860316 | PANOPTIKON | Cytocolor, Inc. | 1986-02-20 |
| K860317 | NEUTROCOLOR | Cytocolor, Inc. | 1986-02-20 |
| K860319 | MEGACOLOR | Cytocolor, Inc. | 1986-02-20 |
| K860320 | GRANULOCOLOR | Cytocolor, Inc. | 1986-02-20 |
| K860321 | LYSOCOLOR | Cytocolor, Inc. | 1986-02-20 |
| K854176 | POLYCHROME IV STAIN | Devetec, Inc. | 1985-10-31 |
| K851481 | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR | Difco Laboratories, Inc. | 1985-04-29 |
| K842930 | GOMORI'S TRICHROME STAIN | E K Ind., Inc. | 1984-09-11 |
| K842727 | SUPERMOUNT | E K Ind., Inc. | 1984-08-03 |
| K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 | Preventive Diagnostics Corp. | 1984-02-10 |
| K833167 | TRICHROME STAIN LG SOLUTION | Sigma Chemical Co. | 1983-10-31 |
| K833388 | IRON STAIN PROCEDURE HT20 | Sigma Chemical Co. | 1983-10-31 |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | American Scientific Products | 1981-08-31 |
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|---|---|---|---|
| 00630414290010 | Atellica HEMA RET/PLTO | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414312484 | Atellica HEMA RET/PLTO | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00613647028643 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028647 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00673693202299 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693202268 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693202244 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693202237 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693202015 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693201995 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693201247 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693089968 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693089944 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693089920 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693089746 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693202312 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-06 |
| 00673693090209 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693090063 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693089647 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693171175 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693088084 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-30 |
| 00673693088091 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-30 |
| 00673693088114 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-30 |
| 00673693088121 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-30 |
| 00613647023198 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647023181 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00673693404471 | Thermo Scientific | RICHARD-ALLAN SCIENTIFIC COMPANY | 2018-06-01 |
| 00673693404426 | Thermo Scientific | RICHARD-ALLAN SCIENTIFIC COMPANY | 2018-06-01 |
| 03610230004647 | ABX FLUOCYTE (0.5L) | HORIBA ABX SAS | 2016-08-23 |
| 03610230004630 | ABX RETIX (0.5L) | HORIBA ABX SAS | 2016-08-16 |