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FDA 510(k)

BIOTROL RUB-E.I.A. TEST G

K-Number: K894544 · 1989-08-30

ApplicantBiotrol, USA, Inc.
Decision Date1989-08-30
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTROL RUB-E.I.A. TEST G is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1989-08-30 under 510(k) number K894544. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL RUB-E.I.A. TEST G?

BIOTROL RUB-E.I.A. TEST G is a medical device that received FDA 510(k) clearance on 1989-08-30. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K894544.

When did BIOTROL RUB-E.I.A. TEST G receive FDA 510(k) clearance?

BIOTROL RUB-E.I.A. TEST G received FDA 510(k) clearance on 1989-08-30, under 510(k) number K894544.

Who is the listed applicant for BIOTROL RUB-E.I.A. TEST G?

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

What is the FDA product code for BIOTROL RUB-E.I.A. TEST G?

The FDA product code for BIOTROL RUB-E.I.A. TEST G is LFX.

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Related Devices (Code: LFX)

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

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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