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FDA 510(k)

COMPLEMENT C3 NEPHELOMETRIC ASSAY

K-Number: K772249 · 1977-12-22

ApplicantKallestad Laboratories, Inc.
Decision Date1977-12-22
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT C3 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 K772249. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLEMENT C3 NEPHELOMETRIC ASSAY?

COMPLEMENT C3 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 K772249.

When did COMPLEMENT C3 NEPHELOMETRIC ASSAY receive FDA 510(k) clearance?

COMPLEMENT C3 NEPHELOMETRIC ASSAY received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772249.

Who is the listed applicant for COMPLEMENT C3 NEPHELOMETRIC ASSAY?

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

What is the FDA product code for COMPLEMENT C3 NEPHELOMETRIC ASSAY?

The FDA product code for COMPLEMENT C3 NEPHELOMETRIC ASSAY is CEW.

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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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