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FDA 510(k)

GOAT ANTISERUM COMPLEMENT C3 NEPHEL.

K-Number: K770964 · 1977-06-24

Decision Date1977-06-24
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTISERUM COMPLEMENT C3 NEPHEL. 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 K770964. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTISERUM COMPLEMENT C3 NEPHEL.?

GOAT ANTISERUM COMPLEMENT C3 NEPHEL. 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 K770964.

When did GOAT ANTISERUM COMPLEMENT C3 NEPHEL. receive FDA 510(k) clearance?

GOAT ANTISERUM COMPLEMENT C3 NEPHEL. received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770964.

Who is the listed applicant for GOAT ANTISERUM COMPLEMENT C3 NEPHEL.?

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 COMPLEMENT C3 NEPHEL.?

The FDA product code for GOAT ANTISERUM COMPLEMENT C3 NEPHEL. is DAK.

Related Clinical Trials

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.

Other records listing Kallestad Laboratories, Inc. as applicant

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.

View all 92 devices →

Related Devices (Code: DAK)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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