MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT— 510(k) K040758
Substantially EquivalentMicrogenics Corp.
FDA 510(k) clearance K040758 for MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT, Substantially Equivalent on 2004-05-28. Applicant: Microgenics Corp.. Device class: 1.
Clearance details
- Applicant
- Microgenics Corp.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
Recent devices under product code DIF
view all- K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
- K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
- K132174 — MULTICHEM WBT
- K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
- K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
More clearances from Microgenics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.