HEMOSIL READIPLAS TIN— 510(k) K122584
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K122584 for HEMOSIL READIPLAS TIN, Substantially Equivalent on 2013-03-24. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- 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
- Bedford, MA, US
Recent devices under product code GJS
view allMore clearances from Instrumentation Laboratory CO
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 K122584
K-number listed on FDA's recall record- Z-1052-2022 — HemosIL ReadiPlasTin, Part No. 0020301400
- Z-0276-2022 — HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
- Z-0077-2019 — Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
- Z-0895-2018 — Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.