510(k) K961423
- Device
- OSOM STREP A TEST
- Applicant
- WYNTEK DIAGNOSTICS, INC.
- 510(k) number
- K961423
- Product code
- GTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-11
- Date received
- 1996-04-12
- 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
- No
Applicant Contact#
- Contact
- SHU-CHING CHENG
- Address
- 6145 Nancy Ridge Dr. Suite 101 San Diego CA US 92121 92121
FDA Registration Numbers#
- 2032682
- 8010383
- 3002792284
- 3012494290
- 2024674
- 3033751096
- 2029372
- 3033507883
- 8010096
- 9611882
- 2030538
- 3021090658
- 3003750284
- 3006716639
- 3017772438
- 1221359
- 3007507973
- 3017662853
- 1119779
Source Documents#
Legacy Summary#
summary
FDA Review#
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