N Latex Iga
FDA 510(k) K952309 · Behring Diagnostics, Inc.
510(k) numberK952309
Submission
- Device name
- N Latex Iga
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- May 17, 1995
- Decision date
- June 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K993927 | Wako Iga Ii-Ha, Immunoglobulin Calibrator Set, Immunoglobulin StandradCZP · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K983359 | IgaCZP · Traditional | Abbott Laboratories | 11/04/1998SE |
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| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K931806 | Iga Subclass Rid Kit for Diagnostic UseCZP · Traditional | The Binding Site, Ltd. | 07/16/1993SE |
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Questions and answers
When was N Latex Iga cleared by the FDA?
N Latex Iga (K952309) received a 510(k) decision of Substantially Equivalent on June 20, 1995, 34 days after the submission was received.
What is the product code of K952309?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.