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FDA 510(k)

BIOTROL BILIRUBIN C & T CONTROL

K-Number: K905280 · 1991-02-04

ApplicantBiotrol, USA, Inc.
Decision Date1991-02-04
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL BILIRUBIN C & T CONTROL 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 1991-02-04 under 510(k) number K905280. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL BILIRUBIN C & T CONTROL?

BIOTROL BILIRUBIN C & T CONTROL is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K905280.

When did BIOTROL BILIRUBIN C & T CONTROL receive FDA 510(k) clearance?

BIOTROL BILIRUBIN C & T CONTROL received FDA 510(k) clearance on 1991-02-04, under 510(k) number K905280.

Who is the listed applicant for BIOTROL BILIRUBIN C & T CONTROL?

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 BILIRUBIN C & T CONTROL?

The FDA product code for BIOTROL BILIRUBIN C & T CONTROL is JJX.

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Other records listing Biotrol, USA, Inc. as applicant

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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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