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FDA 510(k)

ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)

K-Number: K991443 · 1999-06-22

ApplicantRoche Diagnostics Corp.
Decision Date1999-06-22
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K991443. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)?

ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K991443.

When did ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) receive FDA 510(k) clearance?

ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) received FDA 510(k) clearance on 1999-06-22, under 510(k) number K991443.

Who is the listed applicant for ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)?

The FDA product code for ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) is JXM.

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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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