The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Mouse Anti-human B-cell, Cd19/rpe-cy5, Clone Hd37.
Device ID | K980635 |
510k Number | K980635 |
Device Name: | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 |
Classification | Counter, Differential Cell |
Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
Contact | Gretchen M Murray, Ph.d., Rac |
Correspondent | Gretchen M Murray, Ph.d., Rac 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 | 1998-02-19 |
Decision Date | 1998-07-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05700572028345 | K980635 | 000 |