J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO— 510(k) K801669
Substantially EquivalentJ.T. Baker Chemical Co.
FDA 510(k) clearance K801669 for J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO, Substantially Equivalent on 1980-09-16. Applicant: J.T. Baker Chemical Co.. Device class: 2.
Clearance details
- Applicant
- J.T. Baker Chemical Co.
- 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
- Mchenry, IL, 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 J.T. Baker Chemical Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.