Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114
FDA 510(k) K033525 · Dade Behring, Inc.
510(k) numberK033525
Submission
- Device name
- Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- November 7, 2003
- Decision date
- January 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
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| K101203 | Tina-Quant Albumin Gen 2DCF · Traditional | Roche Diagnostics | 09/10/2010SE |
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| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | Kamiya Biomedical Co. | 04/29/2010SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | Beckman Coulter, Inc. | 04/08/2009SE |
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Questions and answers
When was Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114 cleared by the FDA?
Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114 (K033525) received a 510(k) decision of Substantially Equivalent on January 12, 2004, 66 days after the submission was received.
What is the product code of K033525?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.