WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO— 510(k) K001933
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K001933 for WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO, Substantially Equivalent on 2000-07-24. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code DFC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Richmond, VA, US
Recent devices under product code DFC
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view all- K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
- 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.