510(k) K011709
- Device
- UNI-GOLD STREP A TEST KIT
- Applicant
- Trinity Biotech, Plc
- 510(k) number
- K011709
- Product code
- GTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-08
- Date received
- 2001-06-04
- Regulation
- 866.3740
- Classification name
- Antisera, All Groups, Streptococcus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- FIONA CAMPBELL
- Address
- Ida Business Park Ballinasloe IE
FDA Registration Numbers#
- 2030538
- 3006716639
- 3033507883
- 3007507973
- 8010096
- 8010383
- 2032682
- 2029372
- 3017772438
- 3033751096
- 3012494290
- 9611882
- 1119779
- 3003750284
- 1221359
- 3002792284
- 3017662853
- 3021090658
- 2024674