MITOCHONDRIA EIA TEST KIT— 510(k) K940251
Substantially EquivalentDavid A. Fuccillo, Ph.D.
FDA 510(k) clearance K940251 for MITOCHONDRIA EIA TEST KIT, Substantially Equivalent on 1994-05-03. Applicant: David A. Fuccillo, Ph.D.. Device class: 2.
Clearance details
- Applicant
- David A. Fuccillo, Ph.D.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, D.C., DC, US
Recent devices under product code DBM
view all- K181556 — EliA M2 Immunoassay
- K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
- K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
- K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG)
More clearances from David A. Fuccillo, Ph.D.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.