RABBIT ANTISERUM TO HUMAN IGM
Igm, Fitc, Antigen, Antiserum, Control
DAKO CORP.
The following data is part of a premarket notification filed by Dako Corp. with the FDA for Rabbit Antiserum To Human Igm.
Pre-market Notification Details
Device ID | K831907 |
510k Number | K831907 |
Device Name: | RABBIT ANTISERUM TO HUMAN IGM |
Classification | Igm, Fitc, Antigen, Antiserum, Control |
Applicant | DAKO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DFS |
CFR Regulation Number | 866.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-14 |
Decision Date | 1983-07-19 |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
05700572002529 |
K831907 |
000 |
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