The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd3, T-cell/fitc & Cd19, B-cell/rpe.
Device ID | K960531 |
510k Number | K960531 |
Device Name: | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE |
Classification | Counter, Differential Cell |
Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
Contact | Gretchen M Murray |
Correspondent | Gretchen M Murray DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-07 |
Decision Date | 1996-06-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05700572028390 | K960531 | 000 |