PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT— 510(k) K103788
Substantially EquivalentHORIBA ABX SAS
FDA 510(k) clearance K103788 for PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT, Substantially Equivalent on 2011-11-08. Applicant: HORIBA ABX SAS.
Clearance details
- Applicant
- HORIBA ABX SAS
- Product code
- Code CFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Data sourced from openFDA. This site is unofficial and independent of the FDA.