COMPLEMENT C3 NEPHELOMETRIC ASSAY— 510(k) K801363
Substantially EquivalentJ.T. Baker Chemical Co.
FDA 510(k) clearance K801363 for COMPLEMENT C3 NEPHELOMETRIC ASSAY, Substantially Equivalent on 1980-06-30. Applicant: J.T. Baker Chemical Co.. Device class: 2.
Clearance details
- Applicant
- J.T. Baker Chemical Co.
- 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
- Mchenry, IL, 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 J.T. Baker Chemical Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.