510(k) K864074
- Device
- Elastic Stain
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K864074
- Product code
- IAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-29
- Date received
- 1986-10-20
- Regulation
- 864.1850
- Classification name
- Van Gieson'S Stain
- 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
- 2028492
- 9610140
- 3004074729
- 1640981
- 3021584593
- 1831638
Source Documents#
510(k) summary PDF not indicated by FDA