# Pb Diagnostic Systems, Inc.

- Location (FDA's records): Westwood, MA
- FDA decisions: 35 (1988–1994): 35 510(k) clearances
- Product codes: JHI (2), KHO (2), KXT (1), CGS (1), LAN (1), KLS (1), JJQ (1), DDR (1), LCQ (1), CGJ (1), DGE (1), KLT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Hellen Professional Services: 1 (https://510kreport.com/company/hellen-professional-services)

## Its most-cited devices
- K915850: Opus Myoglobin Test System (1992), cited by 1

## Recent decisions
- K940507: Opus FT4 Test System (Jul 28, 1994)
- K934762: Opus Procainamide Test System (Jul 20, 1994)
- K933389: Opus CMV-G (Jun 28, 1994)
- K934137: Opus (R) Serology Controls, Modification (Mar 7, 1994)
- K935229: Opus Digitoxin (Dec 22, 1993)
- K934705: Opus Napa (Nov 22, 1993)
- K933675: Opus Total CK (Sep 8, 1993)
- K933066: Opus Estradiol (Sep 8, 1993)

Source page: https://510kreport.com/company/pb-diagnostic-systems