LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM— 510(k) K953926
Substantially EquivalentInternational Enzymes, Inc.
FDA 510(k) clearance K953926 for LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM, Substantially Equivalent on 1995-09-15. Applicant: International Enzymes, Inc.. Device class: 2.
Clearance details
- Applicant
- International Enzymes, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Marcos, CA, US
Recent devices under product code DCK
view allMore clearances from International Enzymes, Inc.
view all- K011169 — HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
- K963085 — LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
- K953927 — LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
- K950802 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
- K944486 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
Data sourced from openFDA. This site is unofficial and independent of the FDA.