Abbott Architect B12
FDA 510(k) K984108 · Abbott Laboratories
510(k) numberK984108
Submission
- Device name
- Abbott Architect B12
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- November 17, 1998
- Decision date
- February 3, 1999
- 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
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|---|---|---|---|
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| 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 |
| 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 Abbott Architect B12 cleared by the FDA?
Abbott Architect B12 (K984108) received a 510(k) decision of Substantially Equivalent on February 3, 1999, 78 days after the submission was received.
What is the product code of K984108?
The FDA product code is LIG – Radioassay, Intrinsic Factor Blocking Antibody, a Class II (moderate risk) device regulated under 21 CFR 862.1810.