510(k) K954214
- Device
- CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
- Applicant
- VYSIS
- 510(k) number
- K954214
- Product code
- OXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-21
- Date received
- 1995-09-07
- Regulation
- 866.6010
- Classification name
- Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICKI ANASTASI
- Address
- 3100 Woodcreek Dr. Downers Grove IL US 60515 60515
FDA Registration Numbers#
- 3005248192
Source Documents#
Legacy Summary#
summary
FDA Review#
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