ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
FDA 510(k) clearance K141427 · decided 2015-07-24
Clearance details
- K-number
- K141427
- Device name
- ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
- Applicant
- Accumetrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-30
- Decision date
- 2015-07-24
- Days to decision
- 420 days
- Clearance type
- Traditional
- Product code
- JOZ
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The Verif recall (Z-0500-2026) | Accriva Diagnostics, Inc. | 2025-11-13 |