510(k) K871545

Device: New Fuchsin Solution
Applicant: SIGMA DIAGNOSTICS, INC.
510(k) number: K871545
Product code: IDF
Decision: Substantially Equivalent (SESE)
Decision date: 1987-04-29
Date received: 1987-04-14
Regulation: 864.1850
Classification name: Acid, Fuchsin
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
9610140
2916205
3009432145
2247035
1045125

Source Documents#

510(k) summary PDF not indicated by FDA