AMYLASE REAGENT KIT— 510(k) K812447
Substantially EquivalentBioscientific
FDA 510(k) clearance K812447 for AMYLASE REAGENT KIT, Substantially Equivalent on 1981-09-09. Applicant: Bioscientific. Device class: 2.
Clearance details
- Applicant
- Bioscientific
- Product code
- Code KHM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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