# K993254: Immulite 2000 Folic Acid, Model L2KF02, L2KF06

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Nov 12, 1999 after 45 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943705 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943705: Folic Acid, Diagnostic Products Corp. (1994) Summary page 1.

## 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 2, 2018 · Class II · Z-1676-2018: Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur 

## Indications for use
IMMULITE 2000 Folic Acid is for in vitro diagnostic use with the IMMULITE 2000 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/K993254
Methodology: https://510kreport.com/methodology