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510(k) K953927

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM by International Enzymes, Inc. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
August 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

Other clearances by International Enzymes, Inc.

  • K011169 — HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 (May 18, 2001)
  • K963085 — LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (August 20, 1996)
  • K953926 — LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN S (September 15, 1995)
  • K950802 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM (June 1, 1995)
  • K944513 — LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E (December 2, 1994)
  • K944486 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E (December 2, 1994)

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