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FDA 510(k)

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

K-Number: K890609 · 1989-03-16

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1989-03-16
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) 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 1989-03-16 under 510(k) number K890609. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)?

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K890609.

When did IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) receive FDA 510(k) clearance?

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890609.

Who is the listed applicant for IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)?

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 IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)?

The FDA product code for IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) is CGS.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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