Immage Immunochemistry System Transferrin (TRF) Reagent
FDA 510(k) K963427 · Beckman Instruments, Inc.
510(k) numberK963427
Submission
- Device name
- Immage Immunochemistry System Transferrin (TRF) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- August 30, 1996
- Decision date
- October 7, 1996
- 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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| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Immage Immunochemistry System Transferrin (TRF) Reagent cleared by the FDA?
Immage Immunochemistry System Transferrin (TRF) Reagent (K963427) received a 510(k) decision of Substantially Equivalent on October 7, 1996, 38 days after the submission was received.
What is the product code of K963427?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.