# K873049: Triglycerides Gpo Without Free Glycerol

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 28, 1987 after 24 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own

## Recalls of this device
- Dec 14, 2018 · Class II · Z-1125-2019: COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
- May 7, 2015 · Class II · Z-1930-2015: 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/K873049
Methodology: https://510kreport.com/methodology