CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3— 510(k) K970976
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K970976 for CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3, Substantially Equivalent on 1997-04-02. 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.