# K901003: Boehringer Mannheim/Hitachi 747 Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Apr 16, 1990 after 42 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 6, 2004 · Not classified · Z-1432-04: A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Aug 6, 2004 · Not classified · Z-1428-04: A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period

Source page: https://510kreport.com/device/K901003
Methodology: https://510kreport.com/methodology