# K904768: Kodatrol I and II Control and Diluent Set

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Nov 9, 1990 after 18 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II (2004), 7 descendants of its own
- K042477: Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein (2004), 4 descendants of its own
- K041764: The Vitros 5,1 FS Chemistry System (2004), 4 descendants of its own
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace (2004), 2 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class III · Z-0471-2021: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Source page: https://510kreport.com/device/K904768
Methodology: https://510kreport.com/methodology