The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit.
Device ID | K110899 |
510k Number | K110899 |
Device Name: | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT |
Classification | Helicobacter Pylori |
Applicant | GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
Contact | Napoleon Monce |
Correspondent | Napoleon Monce GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-30 |
Decision Date | 2012-02-01 |
Summary: | summary |