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FDA 510(k)

MODIFIED QM300 RHEUMATOID FACTOR TEST

K-Number: K902462 · 1990-06-21

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1990-06-21
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFIED QM300 RHEUMATOID FACTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1990-06-21 under 510(k) number K902462. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED QM300 RHEUMATOID FACTOR TEST?

MODIFIED QM300 RHEUMATOID FACTOR TEST is a medical device that received FDA 510(k) clearance on 1990-06-21. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K902462.

When did MODIFIED QM300 RHEUMATOID FACTOR TEST receive FDA 510(k) clearance?

MODIFIED QM300 RHEUMATOID FACTOR TEST received FDA 510(k) clearance on 1990-06-21, under 510(k) number K902462.

Who is the listed applicant for MODIFIED QM300 RHEUMATOID FACTOR TEST?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED QM300 RHEUMATOID FACTOR TEST?

The FDA product code for MODIFIED QM300 RHEUMATOID FACTOR TEST is DHR.

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Other records listing Kallestad Diag, A Div. of Erbamont, Inc. as applicant

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Related Devices (Code: DHR)

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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