Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A) Lpa Reagent, Lipoprotein(A) Calib
FDA 510(k) K000121 · Beckman Coulter, Inc.
510(k) numberK000121
Submission
- Device name
- Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A) Lpa Reagent, Lipoprotein(A) Calib
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- January 18, 2000
- Decision date
- May 17, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5600
- Specialty
- Immunology
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|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | Diazyme Laboratories, Inc. | 06/16/2026SE |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | Roche Diagnostics Operations | 01/24/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | SENTINEL CH. SpA | 12/22/2022SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | Diazyme Laboratories, Inc. | 03/22/2018SE |
| K123046 | Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/20/2012SE |
| K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional | Roche Diagnostics | 11/29/2012SE |
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | General Atomics | 01/13/2009SE |
| K063838 | Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional | Thermo Electron OY | 09/27/2007SE |
| K050487 | Quantia La(A)DFC · Traditional | Biokit, S.A. | 04/26/2005SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | Kamiya Biomedical Co. | 12/13/2002SE |
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Questions and answers
When was Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A) Lpa Reagent, Lipoprotein(A) Calib cleared by the FDA?
Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A) Lpa Reagent, Lipoprotein(A) Calib (K000121) received a 510(k) decision of Substantially Equivalent on May 17, 2000, 120 days after the submission was received.
What is the product code of K000121?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.