MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL— 510(k) K013995
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K013995 for MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL, Substantially Equivalent on 2001-12-21. Applicant: Medical Analysis Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code JJY
- 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
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More 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.