LUPUS(LE)-LATEX TEST— 510(k) K905531
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K905531 for LUPUS(LE)-LATEX TEST, Substantially Equivalent on 1991-01-25. Applicant: Immco Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code LKI
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Recent devices under product code LKI
view allMore clearances from Immco Diagnostics, Inc.
view all- K172745 — ImmuGlo HEp-2 Elite IFA
- K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA
- K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.