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FDA 510(k)

DIABRITE

K-Number: K822894 · 1982-10-18

ApplicantAntraco, Inc.
Decision Date1982-10-18
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIABRITE is the device name listed in this FDA 510(k) record. The listed applicant is Antraco, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822894. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIABRITE?

DIABRITE is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Antraco, Inc.. The 510(k) number is K822894.

When did DIABRITE receive FDA 510(k) clearance?

DIABRITE received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822894.

Who is the listed applicant for DIABRITE?

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

What is the FDA product code for DIABRITE?

The FDA product code for DIABRITE is EJR.

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.

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Other records listing Antraco, 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.

K822142DIAGLAZE

Related Devices (Code: EJR)

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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