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FDA 510(k)

ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.

K-Number: K802284 · 1980-10-23

ApplicantKallestad Laboratories, Inc.
Decision Date1980-10-23
Product CodeCZQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. 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 1980-10-23 under 510(k) number K802284. The device is classified under product code CZQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.?

ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K802284.

When did ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. receive FDA 510(k) clearance?

ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802284.

Who is the listed applicant for ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.?

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 ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.?

The FDA product code for ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. is CZQ.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: CZQ)

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.

K812327KAPPA & LAMBDA BENCE JONES CONTROLSKallestad 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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