Stains, Chemical Solution
Chemical solution stains are hematology and pathology laboratory reagents formulated as liquid chemical solutions to differentially stain cellular components in blood smears, bone marrow samples, or tissue sections, enabling identification and classification of cell types under the microscope. They are classified as FDA Class 1 and are exempt from Good Manufacturing Practice (GMP) requirements. The product code is LED, regulated under 21 CFR 864.1850, in the Hematology specialty. No premarket notification is required.
Basic Information
- Product Code
- LED
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051409 | SLIVASURE | Aug 08, 2005 | Substantially Equivalent | SCANDINAVIAN FORMULAS, INC. |
| K023046 | SST SALIVA SUPPORTING TABLETS | Dec 02, 2002 | Substantially Equivalent | SINCLAIR PHARMACEUTICALS, LTD. |
| K860795 | SPOTTEST CALCOFLUOR WHITE REAGENT | Mar 12, 1986 | Substantially Equivalent | DIFCO LABORATORIES, INC. |
| K860321 | LYSOCOLOR | Feb 20, 1986 | Substantially Equivalent | CYTOCOLOR, INC. |
| K860320 | GRANULOCOLOR | Feb 20, 1986 | Substantially Equivalent | CYTOCOLOR, INC. |
| K860319 | MEGACOLOR | Feb 20, 1986 | Substantially Equivalent | CYTOCOLOR, INC. |
| K860317 | NEUTROCOLOR | Feb 20, 1986 | Substantially Equivalent | CYTOCOLOR, INC. |
| K860316 | PANOPTIKON | Feb 20, 1986 | Substantially Equivalent | CYTOCOLOR, INC. |
| K854176 | POLYCHROME IV STAIN | Oct 31, 1985 | Substantially Equivalent | DEVETEC, INC. |
| K851481 | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR | Apr 29, 1985 | Substantially Equivalent | DIFCO LABORATORIES, INC. |
| K842930 | GOMORI'S TRICHROME STAIN | Sep 11, 1984 | Substantially Equivalent | E K IND., INC. |
| K842727 | SUPERMOUNT | Aug 03, 1984 | Substantially Equivalent | E K IND., INC. |
| K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 | Feb 10, 1984 | Substantially Equivalent | PREVENTIVE DIAGNOSTICS CORP. |
| K833388 | IRON STAIN PROCEDURE HT20 | Oct 31, 1983 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K833167 | TRICHROME STAIN LG SOLUTION | Oct 31, 1983 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | Aug 31, 1981 | Substantially Equivalent | AMERICAN SCIENTIFIC PRODUCTS |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.