ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4— 510(k) K050768
Substantially EquivalentHamilton Thorne Biosciences
FDA 510(k) clearance K050768 for ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4, Substantially Equivalent on 2005-04-28. Applicant: Hamilton Thorne Biosciences. Device class: 2.
Clearance details
- Applicant
- Hamilton Thorne Biosciences
- Product code
- Code MRX
- Device class
- Class 2
- Regulation
- 21 CFR 884.6200
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Beverly, MA, US
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More clearances from Hamilton Thorne Biosciences
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