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FDA 510(k)

ANTI-SM MICROASSAY

K-Number: K894894 · 1989-08-24

ApplicantDiamedix Corp.
Decision Date1989-08-24
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SM MICROASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1989-08-24 under 510(k) number K894894. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SM MICROASSAY?

ANTI-SM MICROASSAY is a medical device that received FDA 510(k) clearance on 1989-08-24. The listed applicant is Diamedix Corp.. The 510(k) number is K894894.

When did ANTI-SM MICROASSAY receive FDA 510(k) clearance?

ANTI-SM MICROASSAY received FDA 510(k) clearance on 1989-08-24, under 510(k) number K894894.

Who is the listed applicant for ANTI-SM MICROASSAY?

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

What is the FDA product code for ANTI-SM MICROASSAY?

The FDA product code for ANTI-SM MICROASSAY is LJM.

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Other records listing Diamedix Corp. 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: LJM)

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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