510(k) K840798

Device: Amyloid Stain, Congo Red Ht 60
Applicant: SIGMA CHEMICAL CO.
510(k) number: K840798
Product code: ICH
Decision: Substantially Equivalent (SESE)
Decision date: 1984-03-12
Date received: 1984-02-23
Regulation: 864.1850
Classification name: Congo Red
Medical specialty: Hematology
Review panel: Hematology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

2028492
1000138378
1831638
3004074729
3008776165
1937990
1938173
2013736
3009189893
2250039
9610140
1219125
1640981
2022180
2916205
3008174888

Source Documents#

510(k) summary PDF not indicated by FDA