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FDA 510(k)

BIOTROL URINE PROTEINS REAGENT

K-Number: K885053 · 1989-01-30

ApplicantBiotrol, USA, Inc.
Decision Date1989-01-30
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL URINE PROTEINS REAGENT 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 1989-01-30 under 510(k) number K885053. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL URINE PROTEINS REAGENT?

BIOTROL URINE PROTEINS REAGENT is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K885053.

When did BIOTROL URINE PROTEINS REAGENT receive FDA 510(k) clearance?

BIOTROL URINE PROTEINS REAGENT received FDA 510(k) clearance on 1989-01-30, under 510(k) number K885053.

Who is the listed applicant for BIOTROL URINE PROTEINS REAGENT?

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 URINE PROTEINS REAGENT?

The FDA product code for BIOTROL URINE PROTEINS REAGENT is JIR.

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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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