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FDA 510(k)

ALBUMIN NEPHELOMETRIC ASSAY

K-Number: K772248 · 1977-12-22

ApplicantKallestad Laboratories, Inc.
Decision Date1977-12-22
Product Code
DecisionSubstantially Equivalent

Device Summary

ALBUMIN NEPHELOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-12-22 under 510(k) number K772248. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN NEPHELOMETRIC ASSAY?

ALBUMIN NEPHELOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1977-12-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K772248.

When did ALBUMIN NEPHELOMETRIC ASSAY receive FDA 510(k) clearance?

ALBUMIN NEPHELOMETRIC ASSAY received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772248.

Who is the listed applicant for ALBUMIN NEPHELOMETRIC ASSAY?

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

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Other records listing Kallestad 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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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