VERIFY(R) REFERENCE PLASMA— 510(k) K881348
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K881348 for VERIFY(R) REFERENCE PLASMA, Substantially Equivalent on 1988-05-02. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Recent devices under product code GGN
view all- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K161316 — George King Coumadin Plasma
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
More clearances from Organon Teknika Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.