WAKO(TM) AUTOKIT TOTAL PROTEIN— 510(k) K880312
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K880312 for WAKO(TM) AUTOKIT TOTAL PROTEIN, Substantially Equivalent on 1988-03-24. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code CEK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1635
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code CEK
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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
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