Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401
FDA 510(k) K062368 · Wako Chemicals USA, Inc.
Submission
- Device name
- Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- August 14, 2006
- Decision date
- January 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAU – Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6030
- Specialty
- Immunology
The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.
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Questions and answers
When was Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401 cleared by the FDA?
Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401 (K062368) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 170 days after the submission was received.
What is the product code of K062368?
The FDA product code is OAU – Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma, a Class II (moderate risk) device regulated under 21 CFR 866.6030.