510(k) K904675
- Device
- Qbc System Mchc
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K904675
- Product code
- JPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-02
- Date received
- 1990-10-12
- Regulation
- 864.5300
- Classification name
- Red-Cell Indices, Calculated
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CUTSHALL
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
Source Documents#
510(k) summary PDF not indicated by FDA