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FDA 510(k)

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

K-Number: K953926 · 1995-09-15

ApplicantInternational Enzymes, Inc.
Decision Date1995-09-15
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Enzymes, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953926. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM?

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is International Enzymes, Inc.. The 510(k) number is K953926.

When did LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM receive FDA 510(k) clearance?

LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953926.

Who is the listed applicant for LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM?

The FDA 510(k) record lists International Enzymes, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM?

The FDA product code for LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM is DCK.

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Official Source

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