TINA-QUANT COMPLEMENT C3C TEST SYSTEM— 510(k) K012361
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K012361 for TINA-QUANT COMPLEMENT C3C TEST SYSTEM, Substantially Equivalent on 2001-11-29. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code CZW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CZW
view all- K100179 — SPAPLUS
- K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
- K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
- K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
- K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
More clearances from Roche Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.