Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999
FDA 510(k) K033603 · Beckman Coulter, Inc.
510(k) numberK033603
Submission
- Device name
- Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- November 17, 2003
- Decision date
- December 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIG – Radioassay, Intrinsic Factor Blocking Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1810
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240800 | Access Intrinsic Factor AbLIG · Traditional | Beckman Coulter, Inc. | 05/03/2024SE |
| K071346 | Immulisa Intrinsic Factor Antibody ElisaLIG · Traditional | Immco Diagnostics, Inc. | 09/24/2007SE |
| K061841 | Quanta Lite Intrinsic Factor ElisaLIG · Traditional | Inova Diagnostics, Inc. | 12/22/2006SE |
| K993251 | Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6LIG · Traditional | Diagnostic Products Corp. | 11/17/1999SE |
| K984108 | Abbott Architect B12LIG · Traditional | Abbott Laboratories | 02/03/1999SE |
| K903218 | Imx B12LIG · Traditional | Abbott Laboratories | 08/23/1990SE |
| K811927 | 1F Blocking ANTIBODY(57 Co) RadioassayLIG · Traditional | Corning Medical & Scientific | 04/01/1982SE |
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Questions and answers
When was Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999 cleared by the FDA?
Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999 (K033603) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 32 days after the submission was received.
What is the product code of K033603?
The FDA product code is LIG – Radioassay, Intrinsic Factor Blocking Antibody, a Class II (moderate risk) device regulated under 21 CFR 862.1810.