# Trace America, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 22 (1988–2001): 22 510(k) clearances
- Product codes: KHS (3), CJE (2), CDT (2), CKA (2), LBR (2), JGQ (1), JIF (1), CDO (1), JGJ (1), NDW (1), JNF (1), CIT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 14 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sigma Diagnostics, Inc.: 5 (https://510kreport.com/company/sigma-diagnostics)
- Horiba Abx: 4 (https://510kreport.com/company/horiba-abx)
- SENTINEL CH. SpA: 2 (https://510kreport.com/company/sentinel-ch)
- Abbott Diagnostics Mfg., Inc.: 1 (https://510kreport.com/company/abbott-diagnostics-mfg)
- General Atomics: 1 (https://510kreport.com/company/general-atomics)
- Thermo Electron OY: 1 (https://510kreport.com/company/thermo-electron)

## Its most-cited devices
- K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST) (1997), cited by 3
- K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901 (2001), cited by 3
- K971477: Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST) (1997), cited by 3
- K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST) (1998), cited by 1
- K972297: Amylase-Incorporating Dynamic Stabilization Technology - (DST) (1997), cited by 1
- K880798: Acid Phosphatase Reagent (1988), cited by 1

## Recent decisions
- K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901 (Jan 17, 2001)
- K980026: Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST) (Mar 10, 1998)
- K980028: Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) (Feb 2, 1998)
- K980030: Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) (Jan 30, 1998)
- K973869: Trace Reagent Line for the Cobas Mira (Jan 7, 1998)
- K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST) (Jan 2, 1998)
- K972297: Amylase-Incorporating Dynamic Stabilization Technology - (DST) (Jul 17, 1997)
- K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST) (May 27, 1997)

Source page: https://510kreport.com/company/trace-america