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FDA 510(k)

LABELLING CHANGES TO IMPRES-MB-X

K-Number: K903508 · 1990-09-07

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1990-09-07
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LABELLING CHANGES TO IMPRES-MB-X is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K903508. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELLING CHANGES TO IMPRES-MB-X?

LABELLING CHANGES TO IMPRES-MB-X is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K903508.

When did LABELLING CHANGES TO IMPRES-MB-X receive FDA 510(k) clearance?

LABELLING CHANGES TO IMPRES-MB-X received FDA 510(k) clearance on 1990-09-07, under 510(k) number K903508.

Who is the listed applicant for LABELLING CHANGES TO IMPRES-MB-X?

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

What is the FDA product code for LABELLING CHANGES TO IMPRES-MB-X?

The FDA product code for LABELLING CHANGES TO IMPRES-MB-X is JHW.

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Other records listing Intl. Immunoassay Laboratories, Inc. as applicant

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Related Devices (Code: JHW)

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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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