QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY— 510(k) K935554
Substantially EquivalentSyntron Bioresearch, Inc.
FDA 510(k) clearance K935554 for QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY, Substantially Equivalent on 1995-08-30. Applicant: Syntron Bioresearch, Inc.. Device class: 1.
Clearance details
- Applicant
- Syntron Bioresearch, 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
- Carlsbad, CA, US
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More clearances from Syntron Bioresearch, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.