ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)— 510(k) K110394
Substantially EquivalentVital Diagnostics (Manufacturing) Ptyltd
FDA 510(k) clearance K110394 for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON), Substantially Equivalent on 2011-06-09. Applicant: Vital Diagnostics (Manufacturing) Ptyltd. Device class: 2.
Clearance details
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Noble Park, AU
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More clearances from Vital Diagnostics (Manufacturing) Ptyltd
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