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FDA 510(k)

BIOTROL UIBC REAGENT

K-Number: K912795 · 1991-08-12

ApplicantBiotrol, USA, Inc.
Decision Date1991-08-12
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL UIBC 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 1991-08-12 under 510(k) number K912795. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL UIBC REAGENT?

BIOTROL UIBC REAGENT is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K912795.

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

BIOTROL UIBC REAGENT received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912795.

Who is the listed applicant for BIOTROL UIBC 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 UIBC REAGENT?

The FDA product code for BIOTROL UIBC REAGENT is JMO.

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Related Devices (Code: JMO)

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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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