AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)— 510(k) K023396
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K023396 for AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS), Substantially Equivalent on 2002-12-23. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CIJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
Recent devices under product code CIJ
view allMore clearances from Pointe Scientific, Inc.,
view allData sourced from openFDA. This site is unofficial and independent of the FDA.