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FDA 510(k)

ROCHE REAGENT FOR ETHANOL

K-Number: K913125 · 1991-08-12

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-08-12
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR ETHANOL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K913125. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE REAGENT FOR ETHANOL?

ROCHE REAGENT FOR ETHANOL is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K913125.

When did ROCHE REAGENT FOR ETHANOL receive FDA 510(k) clearance?

ROCHE REAGENT FOR ETHANOL received FDA 510(k) clearance on 1991-08-12, under 510(k) number K913125.

Who is the listed applicant for ROCHE REAGENT FOR ETHANOL?

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

What is the FDA product code for ROCHE REAGENT FOR ETHANOL?

The FDA product code for ROCHE REAGENT FOR ETHANOL is DIC.

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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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