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FDA 510(k)

IMX B12

K-Number: K903218 · 1990-08-23

ApplicantAbbott Laboratories
Decision Date1990-08-23
Product CodeLIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX B12 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K903218. The device is classified under product code LIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMX B12?

IMX B12 is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Abbott Laboratories. The 510(k) number is K903218.

When did IMX B12 receive FDA 510(k) clearance?

IMX B12 received FDA 510(k) clearance on 1990-08-23, under 510(k) number K903218.

Who is the listed applicant for IMX B12?

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

What is the FDA product code for IMX B12?

The FDA product code for IMX B12 is LIG.

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Related Devices (Code: LIG)

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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