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FDA 510(k)

HTSH RIABEAD DIAGNOSTIC KIT

K-Number: K810381 · 1981-02-26

ApplicantAbbott Laboratories
Decision Date1981-02-26
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HTSH RIABEAD 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 1981-02-26 under 510(k) number K810381. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HTSH RIABEAD DIAGNOSTIC KIT?

HTSH RIABEAD DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is Abbott Laboratories. The 510(k) number is K810381.

When did HTSH RIABEAD DIAGNOSTIC KIT receive FDA 510(k) clearance?

HTSH RIABEAD DIAGNOSTIC KIT received FDA 510(k) clearance on 1981-02-26, under 510(k) number K810381.

Who is the listed applicant for HTSH RIABEAD 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 HTSH RIABEAD DIAGNOSTIC KIT?

The FDA product code for HTSH RIABEAD DIAGNOSTIC KIT is CGJ.

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Related Devices (Code: CGJ)

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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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