The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Labeled Streptavidin-biotin 2 Kit, And Envision.
Device ID | K951965 |
510k Number | K951965 |
Device Name: | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION |
Classification | Lambda, Antigen, Antiserum, Control |
Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
Contact | Kim M Kosai |
Correspondent | Kim M Kosai DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
Product Code | DEH |
CFR Regulation Number | 866.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-27 |
Decision Date | 1996-07-05 |
Summary: | summary |