510(k) K171976
- Device
- Sofia Strep A+ FIA, Sofia 2 Analyzer
- Applicant
- Quidel Corporation
- 510(k) number
- K171976
- Product code
- GTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-21
- Date received
- 2017-06-30
- Regulation
- 866.3740
- Classification name
- Antigens, All Groups, Streptococcus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Dual Track
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Edward C. Brehm
- Address
- 12544 High Bluff Dr., Suite 200 San Diego, CA US 92130 92130
FDA Registration Numbers#
- 3012073813
- 3010131137
- 3014150341
- 3004043187
- 3007606081
- 3009335633
- 3024463179
- 3010852191
- 1061932
- 1645225
- 3005984081
- 2531491
- 3042471840
- 1616487
- 3002792284
- 3016252795
- 3023322455
- 3027519599
- 3004635103
- 3043127647
- 2024674
- 3012725363
- 3012516456
- 2000007960
- 3033751096
- 3009238284
- 3013296716
- 2027969
- 2060833
- 2435505
- 3017550662
- 3033507883
- 1649661
- 8020790
- 3008517993
- 9611882
- 2030538
- 2030633
- 3043196750
- 3021090658
- 3005641941
- 3016733849
- 3003750284
- 3005360469
- 2244821
- 3007886372
- 3017772438
- 3003917514
- 3006948883
- 2246703
- 1119779
- 3034246205
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary