DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
FDA 510(k) K162208 · Beckman Coulter, Inc.
510(k) numberK162208
Submission
- Device name
- DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- August 5, 2016
- Decision date
- January 9, 2017
- 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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| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 09/04/2019SE |
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| K190686 | Optilite IgM CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
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Questions and answers
When was DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent cleared by the FDA?
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208) received a 510(k) decision of Substantially Equivalent on January 9, 2017, 157 days after the submission was received.
What is the product code of K162208?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.