The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd3, T-cell, Fitc & Cd8, T-cell(suppressor/cytotoxic) Rpe.
Device ID | K955909 |
510k Number | K955909 |
Device Name: | MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) 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 | 1995-12-29 |
Decision Date | 1996-03-28 |
Summary: | summary |