Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
FDA 510(k) K161721 · Diazyme Laboratories
510(k) numberK161721
Submission
- Device name
- Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- June 22, 2016
- Decision date
- September 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CDD – Radioassay, Vitamin B12
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Specialty
- Clinical Chemistry
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| K223289 | Access Vitamin B12CDD · Traditional | Beckman Coulter, Inc. | 12/23/2022SE |
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| K192064 | LIAISON Vitamin B12CDD · Traditional | DiaSorin, Inc. | 10/02/2019SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | Axis-Shield Diagnostics, Ltd. | 10/27/2017SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | Axis-Shield Diagnostics Limited | 07/26/2016SE |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetCDD · Traditional | Roche Diagnostics | 09/24/2015SE |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…CDD · Special | Beckman Coulter, Inc. | 09/16/2014SE |
| K133512 | Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)CDD · Traditional | Siemens Healthcare Diagnostics | 01/02/2014SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | Axis-Shield Diagnostics, Ltd. | 03/22/2013SE |
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Questions and answers
When was Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set cleared by the FDA?
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721) received a 510(k) decision of Substantially Equivalent on September 20, 2016, 90 days after the submission was received.
What is the product code of K161721?
The FDA product code is CDD – Radioassay, Vitamin B12, a Class II (moderate risk) device regulated under 21 CFR 862.1810.