IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA
Igg, Antigen, Antiserum, Control
DAKO CORP.
The following data is part of a premarket notification filed by Dako Corp. with the FDA for Immunogl. Frct. Of Rabbit Antiser.-alpha.
Pre-market Notification Details
Device ID | K812495 |
510k Number | K812495 |
Device Name: | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA |
Classification | Igg, Antigen, Antiserum, Control |
Applicant | DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DEW |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-31 |
Decision Date | 1981-09-23 |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
05700572000273 |
K812495 |
000 |
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