# K930007: Immulite TSH Third Generation Control

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 16, 1993 after 224 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960195: Thyrochek One-Step Rapid TSH Assay (1996), 2 descendants of its own
- K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay (1999), 1 descendant of its own
- K030912: Thyro Test (2003), 0 descendants of its own
- K963916: Immulite Cannabinoids (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K930007
Methodology: https://510kreport.com/methodology