TRF
FDA 510(k) K983167 · Abbott Laboratories
510(k) numberK983167
Submission
- Device name
- TRF
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- September 10, 1998
- Decision date
- November 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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| K063322 | Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…DDG · Traditional | Dade Behring, Inc. | 01/24/2007SE |
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Questions and answers
When was TRF cleared by the FDA?
TRF (K983167) received a 510(k) decision of Substantially Equivalent on November 4, 1998, 55 days after the submission was received.
What is the product code of K983167?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.