510(k) K811011
- Device
- Histochemical Demonstration Of Leukocyte
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K811011
- Product code
- GIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-15
- Date received
- 1981-04-15
- Regulation
- 864.7675
- Classification name
- Test, Leukocyte Peroxidase
- 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#
- 1937990
- 1000138378
- 1938173
- 2025606
Source Documents#
510(k) summary PDF not indicated by FDA