BACI 6 -ADRENOCORTICOTROOP HORMONE— 510(k) K850053
Substantially EquivalentEuro-Diagnostics BV
FDA 510(k) clearance K850053 for BACI 6 -ADRENOCORTICOTROOP HORMONE, Substantially Equivalent on 1985-04-08. Applicant: Euro-Diagnostics BV. Device class: 2.
Clearance details
- Applicant
- Euro-Diagnostics BV
- Product code
- Code CKG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1025
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Old Greenwich, CT, US
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More clearances from Euro-Diagnostics BV
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