510(k) K871544
- Device
- Methyl Green Solution
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K871544
- Product code
- HZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-04-29
- Date received
- 1987-04-14
- Regulation
- 864.1850
- Classification name
- Methyl Green
- 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#
- 3008174888
- 3009189893
- 2022180
- 3004074729
- 2916205
- 9610140
- 1000138378
- 1937990
- 1831638
- 3009432145
- 3008776165
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HZA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844808 | METHYL GREEN-PYRONIN STAIN PROCEDURE HT70 | Sigma Chemical Co. | 1985-02-25 |