TRI-LEVEL TDM CONTROL & I II III— 510(k) K831500
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K831500 for TRI-LEVEL TDM CONTROL & I II III, Substantially Equivalent on 1983-06-30. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.