510(k) K851639
- Device
- ANTI-LEU-12 B CELL REAGENT
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K851639
- Product code
- LJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-02
- Date received
- 1985-04-19
- Regulation
- 864.5220
- Classification name
- Assay, B Lymphocyte Marker
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL J ARNSBERGE
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 3008352382
- 3027394506
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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