The following data is part of a premarket notification filed by Dako Corp. with the FDA for Monoclonal Mouse Anti-human T-cell, Cd2, Clone Mt910 Fitc-conjugated, (anti-cd2,fitc, Mt910).
Device ID | K945692 |
510k Number | K945692 |
Device Name: | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) |
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 | 1994-11-21 |
Decision Date | 1995-01-25 |