# K991111: Buffer Chromogen (R1), Product NO. CA110-01, Edta Reagen (R2), Product NO. CA110-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: May 25, 1999 after 54 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The agents: Buffer/Chromogen(R1), product No. CA110-01 and EDTA Reagent (R2), product No. CA110-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of calcium in serum, plasma and urine.

Source page: https://510kreport.com/device/K991111
Methodology: https://510kreport.com/methodology