# K973469: Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technologies, Inc.
- Decided: Sep 25, 1997 after 21 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.
- (no number) MCC-LiquiChem Unassayed Liquid Chemistry Control, Hematronix, Inc. Levels 1 and 2: named in the summary without a submission number

## Most influential descendants
- K023731: Quickcheck Liquid Chemistry Control (Assayed and Unassayed), Levels 1, 2, and 3 (2002), 0 descendants of its own

## Indications for use
Clinical laboratories performing chemistry assays may use above mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c) above mentioned controls are validated for use with the specific

Source page: https://510kreport.com/device/K973469
Methodology: https://510kreport.com/methodology