Access Intrinsic Factor Ab
FDA 510(k) K240800 · Beckman Coulter, Inc.
510(k) numberK240800
Submission
- Device name
- Access Intrinsic Factor Ab
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- March 25, 2024
- Decision date
- May 3, 2024
- 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 |
|---|---|---|---|
| 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 |
| K033603 | Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…LIG · Traditional | Beckman Coulter, Inc. | 12/19/2003SE |
| 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 Access Intrinsic Factor Ab cleared by the FDA?
Access Intrinsic Factor Ab (K240800) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 39 days after the submission was received.
What is the product code of K240800?
The FDA product code is LIG – Radioassay, Intrinsic Factor Blocking Antibody, a Class II (moderate risk) device regulated under 21 CFR 862.1810.