# K982217: AC/AD Linearity Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Sc Calibrators & Controls, LLC
- Decided: Jul 2, 1998 after 8 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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) ABCim Linearity Verifiers by SC Calibrators & Controls LLC: named in the summary without a submission number

## Indications for use
AC/AD Linearity Verifiers should be used any time it is necessary to confirm the proper calibration and linear operating range of TDM methods and instruments. Quality control/verification requirements should be determined in conformance with local, state and/or Federal regulations or accreditation requirements

Source page: https://510kreport.com/device/K982217
Methodology: https://510kreport.com/methodology