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FDA 510(k)

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P

K-Number: K972721 · 1997-08-06

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1997-08-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL 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 1997-08-06 under 510(k) number K972721. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P?

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K972721.

When did ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P receive FDA 510(k) clearance?

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P received FDA 510(k) clearance on 1997-08-06, under 510(k) number K972721.

Who is the listed applicant for ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL 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 HEMOGLOBIN A1C CONTROL N AND CONTROL P?

The FDA product code for ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P is JJX.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JJX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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