# K915195: Enzymun-Test TSH

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 14, 1992 after 87 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K961491: Elecsys TSH Assay (1996), 7 descendants of its own
- K962573: Elecsys Precicontrol TSH (1996), 2 descendants of its own
- K162606: Elecsys TSH assay, cobas e 801 Immunoassay analyzer (2017), 1 descendant of its own
- K060754: Elecsys TSH Calset W/Models 04738551 (2006), 1 descendant of its own
- K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K915195
Methodology: https://510kreport.com/methodology