# K973629: Precinorm RF, Precipath RF

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 7, 1997 after 13 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962373 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962373: N/T Rheumatology Control SL/1 and SL/2, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant Rheumatoid Factor assay.

Source page: https://510kreport.com/device/K973629
Methodology: https://510kreport.com/methodology