LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM— 510(k) K950802
Substantially EquivalentInternational Enzymes, Inc.
FDA 510(k) clearance K950802 for LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM, Substantially Equivalent on 1995-06-01. Applicant: International Enzymes, Inc.. Device class: 1.
Clearance details
- Applicant
- International Enzymes, 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
- Fallbrook, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.