510(k) K810875
- Device
- FECAL STAINING KIT
- Applicant
- JAYCO PHARMACEUTICALS
- 510(k) number
- K810875
- Product code
- KKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-01
- Date received
- 1981-03-31
- Regulation
- 864.1850
- Classification name
- Sudan Iii
- Medical specialty
- Hematology
- Review panel
- Pathology
- 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#
- 3006365273
- 2013736
- 3008174888
- 1625587
- 2025606
- 1125908
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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