Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter
FDA 510(k) K130122 · Beckman Coulter, Inc.
510(k) numberK130122
Submission
- Device name
- Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- January 17, 2013
- Decision date
- January 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter cleared by the FDA?
Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter (K130122) received a 510(k) decision of Substantially Equivalent on January 7, 2014, 355 days after the submission was received.
What is the product code of K130122?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.