Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
FDA 510(k) K161646 · Diazyme Laboratories
510(k) numberK161646
Submission
- Device name
- Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- June 15, 2016
- Decision date
- November 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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| K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls…CGN · Traditional | Abbott Laboratories | 03/05/2010SE |
| K091332 | Aia-Pack RBC FolateCGN · Traditional | Tosoh Bioscience, Inc. | 10/02/2009SE |
| K082340 | Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…CGN · Traditional | Roche Diagnostics Corp. | 06/19/2009SE |
| K060774 | Folate on the Access Immunoassay Systems, Model A14208CGN · Special | Beckman Coulter, Inc. | 04/21/2006SE |
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Questions and answers
When was Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set cleared by the FDA?
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646) received a 510(k) decision of Substantially Equivalent on November 4, 2016, 142 days after the submission was received.
What is the product code of K161646?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.