Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688
FDA 510(k) K033038 · Beckman Coulter, Inc.
Submission
- Device name
- Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- September 29, 2003
- Decision date
- December 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at…
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Questions and answers
When was Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688 cleared by the FDA?
Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688 (K033038) received a 510(k) decision of Substantially Equivalent on December 29, 2003, 91 days after the submission was received.
What is the product code of K033038?
The FDA product code is NIG – System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.