Submission Details
| 510(k) Number | K133343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2013 |
| Decision Date | January 31, 2014 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
WONDFO RAPID STREP A TEST
Jan 2014
Decision
93d
Days
Class 1
Risk
About This 510(k) Submission
K133343 is an FDA 510(k) clearance for the WONDFO RAPID STREP A TEST, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on January 31, 2014, 93 days after receiving the submission on October 30, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.
Device Classification
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3740 |
Manufacturer
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