WAKO(TM) AUTOKIT UREA N— 510(k) K873335
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K873335 for WAKO(TM) AUTOKIT UREA N, Substantially Equivalent on 1987-10-02. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code CDQ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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- K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
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