The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-gliadin (gaf-3x) Elisa (iga).
Device ID | K083052 |
510k Number | K083052 |
Device Name: | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) |
Classification | Antibodies, Gliadin |
Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
Contact | Kathryn Kohl |
Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
Product Code | MST |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-14 |
Decision Date | 2009-07-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04049016035930 | K083052 | 000 |