WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET— 510(k) K024280
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K024280 for WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET, Substantially Equivalent on 2003-06-06. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, US
Recent devices under product code DCK
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- K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
- K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
Data sourced from openFDA. This site is unofficial and independent of the FDA.