# K921661: Boehringer Mannheim/ Hitachi 911 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 30, 1992 after 84 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 1 (0 Class I)
- 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; 2 cite 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B (2012), 0 descendants of its own
- K113521: Calcium Gen. 2 (2012), 0 descendants of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1929-2015: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine p

Source page: https://510kreport.com/device/K921661
Methodology: https://510kreport.com/methodology