# K971491: Synermed IR 200 Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Synermed, Inc.
- Decided: Jun 26, 1997 after 63 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- 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; 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013654: Precision Systems Analette Chemistry Analyzer (2002), 1 descendant of its own
- K024182: Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents (2003), 0 descendants of its own

## Indications for use
The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample. The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.

Source page: https://510kreport.com/device/K971491
Methodology: https://510kreport.com/methodology