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FDA 510(k)

GOAT ANTISERUM IGG NEPHELOMETRIC

K-Number: K770961 · 1977-06-24

ApplicantKallestad Laboratories, Inc.
Decision Date1977-06-24
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTISERUM IGG NEPHELOMETRIC 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 1977-06-24 under 510(k) number K770961. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTISERUM IGG NEPHELOMETRIC?

GOAT ANTISERUM IGG NEPHELOMETRIC is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770961.

When did GOAT ANTISERUM IGG NEPHELOMETRIC receive FDA 510(k) clearance?

GOAT ANTISERUM IGG NEPHELOMETRIC received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770961.

Who is the listed applicant for GOAT ANTISERUM IGG NEPHELOMETRIC?

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 GOAT ANTISERUM IGG NEPHELOMETRIC?

The FDA product code for GOAT ANTISERUM IGG NEPHELOMETRIC is DEW.

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Related Devices (Code: DEW)

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

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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