ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA— 510(k) K902210
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K902210 for ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA, Substantially Equivalent on 1990-07-03. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- 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
- Raritan, NJ, 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 Ortho Diagnostic Systems, Inc.
view all- K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.