ALK-PHOS BIOPAK GEL— 510(k) K810144
Substantially EquivalentBioware Products
FDA 510(k) clearance K810144 for ALK-PHOS BIOPAK GEL, Substantially Equivalent on 1981-02-02. Applicant: Bioware Products. Device class: 2.
Clearance details
- Applicant
- Bioware Products
- Product code
- Code CIN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CIN
view allMore clearances from Bioware Products
view allData sourced from openFDA. This site is unofficial and independent of the FDA.