# K993014: Modification to Document Thyroid Cal.Ver

- Pathway: 510(k) (Traditional)
- Applicant: Casco-Nerl Diagnostics Corporation (Maine)
- Decided: Nov 26, 1999 after 79 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
Longest line of descent: 2 generations back to K950469 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992034: Document Thyroid Cal*Ver, Casco-Nerl Diagnostics Corporation (Maine) (1999) Summary page 1.

## Indications for use
DOCUMENT Thyroid CAL-VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.

Source page: https://510kreport.com/device/K993014
Methodology: https://510kreport.com/methodology