Dimension Vista Iga Flex Reagent Cartridge Assay
FDA 510(k) K061338 · Dade Behring, Inc.
510(k) numberK061338
Submission
- Device name
- Dimension Vista Iga Flex Reagent Cartridge Assay
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- May 15, 2006
- Decision date
- July 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Dimension Vista Iga Flex Reagent Cartridge Assay cleared by the FDA?
Dimension Vista Iga Flex Reagent Cartridge Assay (K061338) received a 510(k) decision of Substantially Equivalent on July 6, 2006, 52 days after the submission was received.
What is the product code of K061338?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.