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FDA 510(k)

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III

K-Number: K963085 · 1996-08-20

ApplicantInternational Enzymes, Inc.
Decision Date1996-08-20
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III 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 1996-08-20 under 510(k) number K963085. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III?

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is International Enzymes, Inc.. The 510(k) number is K963085.

When did LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III receive FDA 510(k) clearance?

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III received FDA 510(k) clearance on 1996-08-20, under 510(k) number K963085.

Who is the listed applicant for LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III?

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 LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III?

The FDA product code for LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III is JJX.

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Other records listing International Enzymes, Inc. as applicant

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Related Devices (Code: JJX)

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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.

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