alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL— 510(k) K182474
Substantially EquivalentBiosystems S.A.
FDA 510(k) clearance K182474 for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL, Substantially Equivalent on 2019-05-02. Applicant: Biosystems S.A.. Device class: 2.
Clearance details
- Applicant
- Biosystems S.A.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
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More clearances from Biosystems S.A.
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