K-Assay Iga
FDA 510(k) K993213 · Kamiya Biomedical Co.
510(k) numberK993213
Submission
- Device name
- K-Assay Iga
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- September 24, 1999
- Decision date
- November 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | Sebia | 01/08/2015SE |
| K120169 | Interlab Ife Test Using G 26 Ver. 2.0 InstrumentCFF · Traditional | Grifols USA, LLC | 08/24/2012SE |
| K111369 | The Helena V8 Immunodisplacement KitCFF · Traditional | Helena Laboratories Uk, Ltd. | 06/26/2012SE |
| K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentCFF · Traditional | Grifols | 10/13/2011SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | Sebia | 04/17/2009SE |
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| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
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| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Iga cleared by the FDA?
K-Assay Iga (K993213) received a 510(k) decision of Substantially Equivalent on November 23, 1999, 60 days after the submission was received.
What is the product code of K993213?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.