Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74
FDA 510(k) K092740 · Abbott Laboratories
510(k) numberK092740
Submission
- Device name
- Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- September 8, 2009
- Decision date
- March 5, 2010
- 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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| 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 |
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Questions and answers
When was Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74 cleared by the FDA?
Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74 (K092740) received a 510(k) decision of Substantially Equivalent on March 5, 2010, 178 days after the submission was received.
What is the product code of K092740?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.