# K991454: Mouse IGG1 Negative Controls

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jun 21, 1999 after 56 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Gentrak Genclone mouse IgG1, 679.1MC: named in the summary without a submission number

## Indications for use
Mouse IgG;, clone DAK-GO1 Negative Control Reagents are fluorescent conjugated (fluorescein isothiocyanate isomer 1 (FITC), R-Phycoerythrin (RPE), or R-Phycoerythrin-Cyanin 5 (RPE-CYS5)) monoclonal antibodies that have been developed for use as negative control reagents for FITC, RPE or RPE-CYS5 conjugated monoclonal antibodies of the IgG; heavy chain isotype in preparations of normal whole peripheral blood by flow cytometric methods. Negative control reagents are one component of the suggested controls for monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.

Source page: https://510kreport.com/device/K991454
Methodology: https://510kreport.com/methodology