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FDA 510(k)

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

K-Number: K952337 · 1996-02-09

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-02-09
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P 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 1996-02-09 under 510(k) number K952337. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P?

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K952337.

When did ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P receive FDA 510(k) clearance?

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P received FDA 510(k) clearance on 1996-02-09, under 510(k) number K952337.

Who is the listed applicant for ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P?

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 UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P?

The FDA product code for ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P is LCP.

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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.

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