Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit
FDA 510(k) K110899 · Gold Standard Diagnostics
510(k) numberK110899
Submission
- Device name
- Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit
- Applicant
- Gold Standard Diagnostics
Davis, CA, US - Received
- March 30, 2011
- Decision date
- February 1, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| K153661 | ImmunoCard STAT! HpSALYR · Traditional | Meridian Bioscience, Inc. | 03/14/2016SE |
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Questions and answers
When was Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit cleared by the FDA?
Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit (K110899) received a 510(k) decision of Substantially Equivalent on February 1, 2012, 308 days after the submission was received.
What is the product code of K110899?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.