# Pacific Hemostasis

- Location (FDA's records): Huntersville, NC
- FDA decisions: 29 (1978–2000): 29 510(k) clearances
- Product codes: GGN (5), GJS (5), KQG (2), GHM (2), GJT (2), GGC (2), JBQ (1), GIS (1), GIT (1), LCP (1), JOZ (1), GIZ (1)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 15 (0 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dade, Baxter Travenol Diagnostics, Inc.: 4 (https://510kreport.com/company/dade-baxter-travenol-diagnostics)
- Medical Laboratory Automation Systems, Inc.: 4 (https://510kreport.com/company/medical-laboratory-automation-systems)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Medical Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/medical-diagnostic-technologies)

## Firms that cite its devices most
- Wortham Laboratories, Inc.: 9 (https://510kreport.com/company/wortham-laboratories)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Vital Scientific N.V.: 1 (https://510kreport.com/company/vital-scientific)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)
- Fisher Diagnostics: 1 (https://510kreport.com/company/fisher-diagnostics)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- R2 Diagnostics, Inc.: 1 (https://510kreport.com/company/r2-diagnostics)

## Its most-cited devices
- K940082: Thromboscreen Thromboplastin-DS (1995), cited by 3
- K891337: Thromboscreen Aptt Reagent (1989), cited by 2
- K992279: Heparin Control Plasma Level 2 (1999), cited by 1
- K781880: Assay Kit, Thrombo-Screen (1978), cited by 1
- K820450: Thromboscreen (1982), cited by 1
- K994100: Pacific Hemostasis Thromboplastin D (2000), cited by 1

## Recent decisions
- K000679: Thrombostrate Control Plasmas (Mar 24, 2000)
- K994100: Pacific Hemostasis Thromboplastin D (Feb 18, 2000)
- K992130: Pacific Hemostasis Thromboscreen 400C (Sep 3, 1999)
- K992279: Heparin Control Plasma Level 2 (Aug 26, 1999)
- K992278: Heparin Control Plasma Level 1 (Aug 26, 1999)
- K991321: Pacific Hemostasis Thromboscreen 200 (Jun 21, 1999)
- K990046: Pacific Hemostasis Immunodepleted Factor Viii Deficient Plasma (Feb 17, 1999)
- K984129: Coagulation Control Level 1 (Normal) (Dec 1, 1998)

Source page: https://510kreport.com/company/pacific-hemostasis