EQUATE(TM) AQR APO AL/B DUO CONTROL— 510(k) K903122
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K903122 for EQUATE(TM) AQR APO AL/B DUO CONTROL, Substantially Equivalent on 1990-08-02. Applicant: Binax, Inc.. Device class: 2.
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code DFC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- S. Portland, ME, US
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