THROMBOSCREEN THROMBOPLASTIN-DS— 510(k) K940082

Name: FDA 510(k) clearance K940082
Creator: U.S. Food and Drug Administration
Published: 1995-02-14

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K940082 for THROMBOSCREEN THROMBOPLASTIN-DS, Substantially Equivalent on 1995-02-14. 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: 1994-01-07
Decision date: 1995-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pacific Hemostasis

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K000679 — THROMBOSTRATE CONTROL PLASMAS2000-03-24
K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D2000-02-18
K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C1999-09-03
K992278 — HEPARIN CONTROL PLASMA LEVEL 11999-08-26
K992279 — HEPARIN CONTROL PLASMA LEVEL 21999-08-26

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.