510(k) K821318
- Device
- Retic Set
- Applicant
- R & D SYSTEMS, INC.
- 510(k) number
- K821318
- Product code
- KJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-02
- Date received
- 1982-05-04
- Regulation
- 864.1850
- Classification name
- Brilliant Cresyl Blue
- 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#
- 2250039
- 1625587
- 9610140
- 3006365273
- 1125908
Source Documents#
510(k) summary PDF not indicated by FDA