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FDA 510(k)

TRIOBEAD-125 DIAGNOSTIC KIT

K-Number: K771236 · 1977-08-03

Decision Date1977-08-03
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIOBEAD-125 DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771236. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIOBEAD-125 DIAGNOSTIC KIT?

TRIOBEAD-125 DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Abbott Laboratories. The 510(k) number is K771236.

When did TRIOBEAD-125 DIAGNOSTIC KIT receive FDA 510(k) clearance?

TRIOBEAD-125 DIAGNOSTIC KIT received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771236.

Who is the listed applicant for TRIOBEAD-125 DIAGNOSTIC KIT?

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

What is the FDA product code for TRIOBEAD-125 DIAGNOSTIC KIT?

The FDA product code for TRIOBEAD-125 DIAGNOSTIC KIT is CEC.

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 Abbott Laboratories 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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Related Devices (Code: CEC)

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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