WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401— 510(k) K062368
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K062368 for WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401, Substantially Equivalent on 2007-01-31. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code OAU
- Device class
- Class 2
- Regulation
- 21 CFR 866.6030
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, US
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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
- K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
Data sourced from openFDA. This site is unofficial and independent of the FDA.