Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
FDA 510(k) clearance K200898 · decided 2021-09-21
Clearance details
- K-number
- K200898
- Device name
- Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
- Applicant
- Medicon Hellas S.A
- Decision
- Substantially Equivalent
- Date received
- 2020-04-03
- Decision date
- 2021-09-21
- Days to decision
- 536 days
- Clearance type
- Traditional
- Product code
- CIX
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gerakas, GR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.