AMYLASE— 510(k) K980013
Substantially EquivalentAc Biochemicals, Inc.
FDA 510(k) clearance K980013 for AMYLASE, Substantially Equivalent on 1998-02-04. Applicant: Ac Biochemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Ac Biochemicals, 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
- Irvine, CA, US
Recent devices under product code CIJ
view allMore clearances from Ac Biochemicals, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.