WAKO(TM) IGA-HA DIRECT— 510(k) K880803
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K880803 for WAKO(TM) IGA-HA DIRECT, Substantially Equivalent on 1988-03-29. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.