The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Multitest Cd3/cd8/cd45/cd4.
Device ID | K974360 |
510k Number | K974360 |
Device Name: | MULTITEST CD3/CD8/CD45/CD4 |
Classification | Counter, Differential Cell |
Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
Contact | Cindy Morrow |
Correspondent | Cindy Morrow BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-19 |
Decision Date | 1998-03-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00382903404995 | K974360 | 000 |