FDA 510(k)

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

K-Number: K032453 · 2003-08-28

Decision Date2003-08-28

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2003-08-28 under 510(k) number K032453. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL?

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL is a medical device that received FDA 510(k) clearance on 2003-08-28. The listed applicant is Bionostics, Inc.. The 510(k) number is K032453.

When did ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL receive FDA 510(k) clearance?

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL received FDA 510(k) clearance on 2003-08-28, under 510(k) number K032453.

Who is the listed applicant for ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL?

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

What is the FDA product code for ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL?

The FDA product code for ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL is JJY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.