# K993251: Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Nov 17, 1999 after 50 days
- Product code: LIG (Radioassay, Intrinsic Factor Blocking Antibody)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DPC's IMMULITE® Vitamin B12: named in the summary without a submission number

## Most influential descendants
- K060929: Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test,L5KFO6-6 (2006), 0 descendants of its own

## Recalls of this device
- Jan 24, 2005 · Not classified · Z-0537-05: A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.

## Indications for use
IMMULITE 2000 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

Source page: https://510kreport.com/device/K993251
Methodology: https://510kreport.com/methodology