LIQUID AMYLASE (CNPG3) REAGENT SET— 510(k) K940735
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K940735 for LIQUID AMYLASE (CNPG3) REAGENT SET, Substantially Equivalent on 1994-08-01. 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
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