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FDA 510(k)

FLUORESCENT ANTI. ANTI-HUMAN C3

K-Number: K771583 · 1977-09-02

ApplicantBurroughs Wellcome Co.
Decision Date1977-09-02
Product CodeDAC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCENT ANTI. ANTI-HUMAN C3 is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K771583. The device is classified under product code DAC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCENT ANTI. ANTI-HUMAN C3?

FLUORESCENT ANTI. ANTI-HUMAN C3 is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K771583.

When did FLUORESCENT ANTI. ANTI-HUMAN C3 receive FDA 510(k) clearance?

FLUORESCENT ANTI. ANTI-HUMAN C3 received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771583.

Who is the listed applicant for FLUORESCENT ANTI. ANTI-HUMAN C3?

The FDA 510(k) record lists Burroughs Wellcome Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUORESCENT ANTI. ANTI-HUMAN C3?

The FDA product code for FLUORESCENT ANTI. ANTI-HUMAN C3 is DAC.

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Other records listing Burroughs Wellcome Co. 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.

K820069WELLCOGEN GROUP BK813508SAC-CELK810215DAC-CEL HCGK810214DAC-CEL DIAGNATALK810212DAC-CEL T3 UPTAKEK810213DAC-CEL TSH

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Related Devices (Code: DAC)

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.

K891904EZ COMPLEMENT C1Diamedix Corp.

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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