Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System
FDA 510(k) K950292 · Miles, Inc.
510(k) numberK950292
Submission
- Device name
- Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System
- Applicant
- Miles, Inc.
Tarrytown, NY, US - Received
- January 25, 1995
- Decision date
- May 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
|---|---|---|
| K950353 | Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJJE · Traditional | 04/20/1995SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | 03/13/1995SE |
| K945655 | Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test…CGX · Traditional | 01/05/1995SE |
| K941171 | Technicon H* 3 RTC System (In-Vitro Diagnostic System)GKZ · Traditional | 12/14/1994SE |
| K943376 | Opera SystemJJC · Traditional | 09/14/1994SE |
| K941156 | Technison Axon SystemKHS · Traditional | 04/26/1994SE |
| K933682 | Direct Amylase (Ec 3.2.1.1) Method for Technicon SystemsJFJ · Traditional | 04/12/1994SE |
| K935287 | Iron -Ii (Fe-Ii) Method/Tech Chem 1(R) 1+TM SystemJIY · Traditional | 01/03/1994SE |
| K933478 | Technicon H*1 Systems, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
| K933475 | Technicon H* 2 System, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
Questions and answers
When was Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System cleared by the FDA?
Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System (K950292) received a 510(k) decision of Substantially Equivalent on May 2, 1995, 97 days after the submission was received.
What is the product code of K950292?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.