BINAX STREP A TEST— 510(k) K960712
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K960712 for BINAX STREP A TEST, Substantially Equivalent on 1996-03-22. Applicant: Binax, Inc.. Device class: 1.
Clearance details
- Applicant
- Binax, Inc.
- 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
- Portland, ME, US
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More clearances from Binax, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.