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510(k) K011169

HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 by International Enzymes, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
April 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by International Enzymes, Inc.

  • K963085 — LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (August 20, 1996)
  • K953927 — LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SY (September 15, 1995)
  • 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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