No-Boil Folate Kit #RP-500
FDA 510(k) K800914 · Ria Products, Inc.
510(k) numberK800914
Submission
- Device name
- No-Boil Folate Kit #RP-500
- Applicant
- Ria Products, Inc.
Mchenry, IL, US - Received
- April 21, 1980
- Decision date
- May 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K223590 | Access Folate AssayCGN · Traditional | Beckman Coulter, Inc. | 08/23/2023SE |
| K192586 | LIAISON® FolateCGN · Traditional | DiaSorin, Inc. | 05/06/2020SE |
| K172201 | Atellica IM Folate AssayCGN · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/12/2018SE |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN · Traditional | Diazyme Laboratories | 11/04/2016SE |
| K141426 | Elecsys Folate IIICGN · Traditional | Roche Diagnostics | 10/17/2014SE |
| K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetCGN · Special | Roche Diagnostics | 05/12/2011SE |
| 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 |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K813310 | No-Hoil Combostat II KitCDD · Traditional | 12/17/1981SE |
| K802969 | Cortisol 125-I Radioimmunoassay KitCGR · Traditional | 01/02/1981SE |
| K801579 | Vitamin B12 - No-Boil KitCDD · Traditional | 10/23/1980SE |
| K801578 | Combostat - No-Boil KitCDD · Traditional | 10/23/1980SE |
| K800710 | Ferritiron Kit Cat. #RP-1100JQG · Traditional | 05/14/1980SE |
| K781844 | Ferritin KitJMG · Traditional | 01/10/1979SE |
| K781769 | Iron 59 KitJJA · Traditional | 12/04/1978SE |
| K780148 | Ria for Folates & Vit. B12, Combo KitCGN · Traditional | 03/03/1978SE |
Questions and answers
When was No-Boil Folate Kit #RP-500 cleared by the FDA?
No-Boil Folate Kit #RP-500 (K800914) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 17 days after the submission was received.
What is the product code of K800914?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.