STREPTEX ACID EXTRACTION KIT— 510(k) K910797
Substantially EquivalentWellcome Diagnostics
FDA 510(k) clearance K910797 for STREPTEX ACID EXTRACTION KIT, Substantially Equivalent on 1991-03-29. Applicant: Wellcome Diagnostics. Device class: 1.
Clearance details
- Applicant
- Wellcome Diagnostics
- 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
- Research Triangle Pk, NC, US
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More clearances from Wellcome Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.