FOLATE/B12 Duo-Bead Radioassay
FDA 510(k) K822241 · Abbott Laboratories
510(k) numberK822241
Submission
- Device name
- FOLATE/B12 Duo-Bead Radioassay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 27, 1982
- Decision date
- October 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091287 | Vs-Sense TestCEN · Traditional | Common Sense , Ltd. | 08/31/2009SE |
| K071100 | Amniscreen Home Detection Liner KitCEN · Traditional | Common Sense , Ltd. | 10/15/2007SE |
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | Germaine Laboratories, Inc. | 10/26/2005SE |
| K040008 | Quickvue Advance PH and Amines GLL TestCEN · Traditional | Quidel Corp. | 04/29/2004SE |
| K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsCEN · Traditional | Uridynamics, Inc. | 04/14/2003SE |
| K962718 | Femexam TestcardCEN · Traditional | Litmus Concepts, Inc. | 02/07/1997SE |
| K840827 | Kyotest 5VCEN · Traditional | Kyoto Diagnostics, Inc. | 05/14/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | Syn-Kit, Inc. | 06/12/1983SE |
| K830979 | Helena Biostrip PHCEN · Traditional | Helena Laboratories | 05/05/1983SE |
| K830091 | Lith a Test TMCEN · Traditional | Lenal Creative Approaches, Inc. | 02/15/1983SE |
More from Lenal Creative Approaches, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was FOLATE/B12 Duo-Bead Radioassay cleared by the FDA?
FOLATE/B12 Duo-Bead Radioassay (K822241) received a 510(k) decision of Substantially Equivalent on October 26, 1982, 91 days after the submission was received.
What is the product code of K822241?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.