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FDA 510(k)

FLUORESCEIN CONJUGATED

K-Number: K772128 · 1977-11-22

ApplicantKallestad Laboratories, Inc.
Decision Date1977-11-22
Product CodeDCE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCEIN CONJUGATED 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 1977-11-22 under 510(k) number K772128. The device is classified under product code DCE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCEIN CONJUGATED?

FLUORESCEIN CONJUGATED is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K772128.

When did FLUORESCEIN CONJUGATED receive FDA 510(k) clearance?

FLUORESCEIN CONJUGATED received FDA 510(k) clearance on 1977-11-22, under 510(k) number K772128.

Who is the listed applicant for FLUORESCEIN CONJUGATED?

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 FLUORESCEIN CONJUGATED?

The FDA product code for FLUORESCEIN CONJUGATED is DCE.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: DCE)

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.

K781951ANTISERA, RHODAMINE CONJUGATED FRAGMENTKallestad Laboratories, Inc.

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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