The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Igg1 Negative Controls.
Device ID | K991454 |
510k Number | K991454 |
Device Name: | MOUSE IGG1 NEGATIVE CONTROLS |
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 | 1999-04-26 |
Decision Date | 1999-06-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05700572028499 | K991454 | 000 |
05700572028482 | K991454 | 000 |
05700572028475 | K991454 | 000 |