N/T Protein Control
FDA 510(k) K032237 · Dade Behring, Inc.
510(k) numberK032237
Submission
- Device name
- N/T Protein Control
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- July 21, 2003
- Decision date
- September 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
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| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was N/T Protein Control cleared by the FDA?
N/T Protein Control (K032237) received a 510(k) decision of Substantially Equivalent on September 5, 2003, 46 days after the submission was received.
What is the product code of K032237?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.