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FDA 510(k)

IMMUFUGE DISP. LINER

K-Number: K780281 · 1978-03-02

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1978-03-02
Product CodeKSO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUFUGE DISP. LINER is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-03-02 under 510(k) number K780281. The device is classified under product code KSO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUFUGE DISP. LINER?

IMMUFUGE DISP. LINER is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K780281.

When did IMMUFUGE DISP. LINER receive FDA 510(k) clearance?

IMMUFUGE DISP. LINER received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780281.

Who is the listed applicant for IMMUFUGE DISP. LINER?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUFUGE DISP. LINER?

The FDA product code for IMMUFUGE DISP. LINER is KSO.

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Other records listing Dade, Baxter Travenol Diagnostics, 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.

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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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