Device Classification Name |
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
|
510(k) Number |
K954214 |
Device Name |
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT |
Applicant |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
VICKI ANASTASI |
Correspondent |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
VICKI ANASTASI |
Regulation Number | 866.6010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/07/1995 |
Decision Date | 01/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|