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FDA 510(k)

FLUORESCEIN CONJUG. FRACT. MONO. ANTI.

K-Number: K772345 · 1978-01-05

ApplicantKallestad Laboratories, Inc.
Decision Date1978-01-05
Product CodeDCB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCEIN CONJUG. FRACT. MONO. ANTI. 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 1978-01-05 under 510(k) number K772345. The device is classified under product code DCB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCEIN CONJUG. FRACT. MONO. ANTI.?

FLUORESCEIN CONJUG. FRACT. MONO. ANTI. is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K772345.

When did FLUORESCEIN CONJUG. FRACT. MONO. ANTI. receive FDA 510(k) clearance?

FLUORESCEIN CONJUG. FRACT. MONO. ANTI. received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772345.

Who is the listed applicant for FLUORESCEIN CONJUG. FRACT. MONO. ANTI.?

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 CONJUG. FRACT. MONO. ANTI.?

The FDA product code for FLUORESCEIN CONJUG. FRACT. MONO. ANTI. is DCB.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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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