The following data is part of a premarket notification filed by Dako Corp. with the FDA for Immunogl. Frct. Of Rabbit Antiser.-macro.
Device ID | K812493 |
510k Number | K812493 |
Device Name: | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO |
Classification | Alpha-2-macroglobulin, Antigen, Antiserum, Control |
Applicant | DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DEB |
CFR Regulation Number | 866.5620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-31 |
Decision Date | 1981-09-23 |