N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
FDA 510(k) K233663 · Siemens Healthcare Diagnostics Products GmbH
510(k) numberK233663
Submission
- Device name
- N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- November 15, 2023
- Decision date
- December 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K191635 | Optilite IgM KitCFN · Special | The Binding Site Group , Ltd. | 07/15/2019SE |
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| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
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Questions and answers
When was N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) cleared by the FDA?
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 28 days after the submission was received.
What is the product code of K233663?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.