CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING— 510(k) K973389
Substantially EquivalentVentana Medical Systems, Inc.
FDA 510(k) clearance K973389 for CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING, Substantially Equivalent on 1997-10-03. Applicant: Ventana Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventana Medical Systems, Inc.
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code DEM
view all- K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- K063610 — DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
- K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- K050596 — QUANTIA A1-AT
More clearances from Ventana Medical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.