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FDA 510(k)

BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT

K-Number: K873117 · 1987-08-31

ApplicantBiotrol, USA, Inc.
Decision Date1987-08-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL GLUCOSE ENZYMATIQUE COLOR 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 1987-08-31 under 510(k) number K873117. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT?

BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT is a medical device that received FDA 510(k) clearance on 1987-08-31. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K873117.

When did BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT receive FDA 510(k) clearance?

BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT received FDA 510(k) clearance on 1987-08-31, under 510(k) number K873117.

Who is the listed applicant for BIOTROL GLUCOSE ENZYMATIQUE COLOR 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 GLUCOSE ENZYMATIQUE COLOR REAGENT?

The FDA product code for BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT is CGA.

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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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