510(k) K864531
- Device
- Tissue Gram Stain
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K864531
- Product code
- ICF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-22
- Date received
- 1986-11-17
- Regulation
- 864.1850
- Classification name
- Crystal Violet For Histology
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM STARKWEATHER
- Address
- P.O. Box 14508 St. Louis MO US 63178 63178
FDA Registration Numbers#
- 3007496191
- 1937990
- 8010383
- 9610140
- 1219125
- 1625587
- 3002805583
- 1000138378
- 3006365273
- 1045125
- 3004074729
- 2247035
- 3009189893
- 2250039
- 2022180
- 3010152370
- 1125908
- 3017970519
- 1831638
- 3009432145
- 1711690
- 2916205
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ICF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | 1984-10-01 |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | 1984-08-03 |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | 1982-06-03 |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | 1979-12-18 |