# K936130: Cobas-FP Reagent for Phenobarbital and Cobas-FP Phenobarbital Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Mar 11, 1994 after 78 days
- Product code: LGQ (Fluorescence Polarization Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K031856: Preciset TDM I and Preciset TDM II Calibrators (2003), 1 descendant of its own
- K091617: QMS Lidocaine Calibrators, Model 0374678 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K936130
Methodology: https://510kreport.com/methodology