510(k) K841026
- Device
- Manual Blood Cell Counting Device
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K841026
- Product code
- GKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-04-04
- Date received
- 1984-03-12
- Regulation
- 864.6160
- Classification name
- Hand-Tally, Differential
- 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#
- 2249760
- 3010194621
- 3006697110
Source Documents#
510(k) summary PDF not indicated by FDA