QKO (TM) AMYLASE B-HA— 510(k) K864303
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K864303 for QKO (TM) AMYLASE B-HA, Substantially Equivalent on 1986-12-31. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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