UNI-GOLD STREP A TEST KIT— 510(k) K011709
Substantially EquivalentTrinity Biotech, Plc
FDA 510(k) clearance K011709 for UNI-GOLD STREP A TEST KIT, Substantially Equivalent on 2001-11-08. Applicant: Trinity Biotech, Plc. Device class: 1.
Clearance details
- Applicant
- Trinity Biotech, Plc
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballinasloe, IE
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More clearances from Trinity Biotech, Plc
view allData sourced from openFDA. This site is unofficial and independent of the FDA.