510(k) K923951
- Device
- CD8 CYTOSPHERES KIT
- Applicant
- COULTER ELECTRONICS, INC.
- 510(k) number
- K923951
- Product code
- MAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-25
- Date received
- 1992-08-06
- Regulation
- 864.5220
- Classification name
- Dna-probe, B And T Lymphocyte
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARDSON-JONES
- Address
- 600 W. 20th St. Hialeah FL US 33010 33010
Source Documents#
Legacy Summary#
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FDA Review#
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