# K965232: Caltag Cal-Lyse

- Pathway: 510(k) (Traditional)
- Applicant: Caltag Laboratories, Inc.
- Decided: May 14, 1997 after 134 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) Coulter CD19 RD1 monoclonal antibody: named in the summary without a submission number
- (no number) Coulter CD19 FITC monoclonal antibody: named in the summary without a submission number
- (no number) Caltag CD19 R-PE monoclonal antibody: named in the summary without a submission number
- (no number) Caltag CD19 TRI-COLOR monoclonal antibody: named in the summary without a submission number

## Indications for use
Caltag Cal-Lyse is a lysis solution to enable the lysis of erythrocytes in samples of anticoagulated human peripheral blood. Cal-Lyse lysing solution is intended as an aid in the enumeration of leukocytes that have been stained with Caltag monoclonal antibodies for analysis by flow cytometric methods.

Source page: https://510kreport.com/device/K965232
Methodology: https://510kreport.com/methodology