# K060929: Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test,L5KFO6-6

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corporation
- Decided: Apr 28, 2006 after 23 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943705 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993251: Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6, Diagnostic Products Corp. (1999) Summary page 2.
- K993254: Immulite 2000 Folic Acid, Model L2KF02, L2KF06, Diagnostic Products Corp. (1999) Summary page 4.

## Indications for use
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia. The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K060929
Methodology: https://510kreport.com/methodology