MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL— 510(k) K031890
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K031890 for MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL, Substantially Equivalent on 2003-07-16. Applicant: Medical Analysis Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
Recent devices under product code JJX
view allMore clearances from Medical Analysis Systems, Inc.
view all- K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
- K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
- K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
- K032826 — MAS PAR TDM
- K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K031890
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031890.
Data sourced from openFDA. This site is unofficial and independent of the FDA.