# Trace Scientific, Ltd.

- Location (FDA's records): Clayton, Vic 3168, AU
- FDA decisions: 55 (1986–1998): 55 510(k) clearances
- Product codes: CDT (4), CKA (4), CIG (4), CIT (4), CIX (3), CGS (3), CDQ (3), CHH (3), JMO (2), CFJ (2), CIC (2), JPZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)

## Firms that cite its devices most
- Sigma Diagnostics, Inc.: 4 (https://510kreport.com/company/sigma-diagnostics)
- Careside, Inc.: 1 (https://510kreport.com/company/careside)

## Its most-cited devices
- K962890: Cholesterol-Incorporating  Dynamic Stab Tech (DST) (1996), cited by 2
- K961114: Ast Incorporating DST (1996), cited by 2
- K870365: Direct Bilirubin Reagent - Acid Diazo Method (1987), cited by 1

## Recent decisions
- K982121: Enzymatic Mitochondrial Antibody (M2) Reagent (Sep 17, 1998)
- K981123: UREA (Apr 24, 1998)
- K962890: Cholesterol-Incorporating  Dynamic Stab Tech (DST) (Sep 27, 1996)
- K961114: Ast Incorporating DST (May 23, 1996)
- K961123: Alt Incorporating DST (Apr 25, 1996)
- K952488: Trace Cobas Mira Range (Oct 13, 1995)
- K932713: Trace Transferrin Reagent (Sep 30, 1993)
- K923322: Trace Albumin-MR Reagent (Sep 11, 1992)

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