ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP— 510(k) K062180
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K062180 for ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP, Substantially Equivalent on 2006-10-02. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- 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
- Montpellier, FR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.