FDA 510(k)

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM

K-Number: K950802 · 1995-06-01

Decision Date1995-06-01

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 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 1995-06-01 under 510(k) number K950802. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM?

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is International Enzymes, Inc.. The 510(k) number is K950802.

When did LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM receive FDA 510(k) clearance?

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM received FDA 510(k) clearance on 1995-06-01, under 510(k) number K950802.

Who is the listed applicant for LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 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 I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM?

The FDA product code for LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM is JJY.

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Other records listing International Enzymes, Inc. as applicant

K011169HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM K953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM K944513LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E K944486LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E

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Related Devices (Code: JJY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.