PACIFIC HEMOSTASIS THROMBOPLASTIN D— 510(k) K994100
Substantially EquivalentPacific Hemostasis
FDA 510(k) clearance K994100 for PACIFIC HEMOSTASIS THROMBOPLASTIN D, Substantially Equivalent on 2000-02-18. Applicant: Pacific Hemostasis. Device class: 2.
Clearance details
- Applicant
- Pacific Hemostasis
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntersville, NC, US
Recent devices under product code GJS
view allMore clearances from Pacific Hemostasis
view allAdverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K994100
K-number listed on FDA's recall record- Z-1502-2025 — Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Z-1503-2025 — Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994100.
Data sourced from openFDA. This site is unofficial and independent of the FDA.