510(k) K822733
- Device
- Sigma Reagent System No. 885
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K822733
- Product code
- JBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-03
- Date received
- 1982-09-08
- Regulation
- 864.7100
- Classification name
- Cell Enzymes (Erythrocytic And Leukocytic)
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1221359
Source Documents#
510(k) summary PDF not indicated by FDA