510(k) K771524

Device: HISTOCHEMICAL FERRIC IRON SET
Applicant: Harleco
510(k) number: K771524
Product code: IAE
Decision: Substantially Equivalent (SESE)
Decision date: 1977-08-22
Date received: 1977-08-08
Regulation: 864.1850
Classification name: Hematoxylin, Iron, Weigert'S
Medical specialty: Hematology
Review panel: Hematology
Device class: 1
Clearance type: Traditional
Third party reviewed: N

Applicant Contact#

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

FDA Registration Numbers#

3008174888
3004074729
1000138378
2013736
1937990
1831638
1938173
3017970519
2250039

Source Documents#

510(k) summary PDF not indicated by FDA