MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)— 510(k) K012138
Substantially EquivalentChroma Vision Medical Systems, Inc.
FDA 510(k) clearance K012138 for MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM), Substantially Equivalent on 2002-09-30. Applicant: Chroma Vision Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Chroma Vision Medical Systems, Inc.
- Product code
- Code MYA
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code MYA
view all- K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- K170028 — FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
- K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- K120663 — MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
- K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
More clearances from Chroma Vision Medical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.