510(k) K813413
- Device
- Lectin H
- Applicant
- AMERICAN DADE
- 510(k) number
- K813413
- Product code
- KSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-04
- Date received
- 1981-12-07
- Regulation
- 864.9550
- Classification name
- Lectins And Protectins
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2250051
- 3012963943
- 3017237798
- 1034569
- 1319681
- 3000308930
- 3011683976
- 3002642396
Source Documents#
510(k) summary PDF not indicated by FDA