VERIFYNOW-P2Y12 ASSAY— 510(k) K051231
Substantially EquivalentAccumetrics, Inc.
FDA 510(k) clearance K051231 for VERIFYNOW-P2Y12 ASSAY, Substantially Equivalent on 2005-08-05. Applicant: Accumetrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Accumetrics, Inc.
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Recalls naming K051231
K-number listed on FDA's recall record- Z-1853-2012 — VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
- Z-1854-2012 — VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051231.
Data sourced from openFDA. This site is unofficial and independent of the FDA.