Submission Details
| 510(k) Number | K110899 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2011 |
| Decision Date | February 01, 2012 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
Feb 2012
Decision
308d
Days
Class 1
Risk
About This 510(k) Submission
K110899 is an FDA 510(k) clearance for the GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on February 1, 2012, 308 days after receiving the submission on March 30, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.
Device Classification
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3110 |
Manufacturer
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