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FDA 510(k)

ROCHE CONTROL SERUM N

K-Number: K954655 · 1995-12-21

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-12-21
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE CONTROL SERUM N 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 1995-12-21 under 510(k) number K954655. 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 CONTROL SERUM N?

ROCHE CONTROL SERUM N is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K954655.

When did ROCHE CONTROL SERUM N receive FDA 510(k) clearance?

ROCHE CONTROL SERUM N received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954655.

Who is the listed applicant for ROCHE CONTROL SERUM N?

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 CONTROL SERUM N?

The FDA product code for ROCHE CONTROL SERUM N is JJY.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JJY)

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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