VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS— 510(k) K033300
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K033300 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS, Substantially Equivalent on 2003-11-05. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Recalls naming K033300
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.