ENZYMATIC ALPHA-AMYLASE REAGENT KIT— 510(k) K850639
Substantially EquivalentBio-Analytics Laboratories, Inc.
FDA 510(k) clearance K850639 for ENZYMATIC ALPHA-AMYLASE REAGENT KIT, Substantially Equivalent on 1985-03-05. Applicant: Bio-Analytics Laboratories, Inc..
Clearance details
- Applicant
- Bio-Analytics Laboratories, Inc.
- Product code
- Code CIW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm City, FL, US
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