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FDA 510(k)

COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT

K-Number: K853009 · 1986-03-04

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1986-03-04
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT 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 1986-03-04 under 510(k) number K853009. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT?

COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K853009.

When did COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT receive FDA 510(k) clearance?

COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT received FDA 510(k) clearance on 1986-03-04, under 510(k) number K853009.

Who is the listed applicant for COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT?

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 COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT?

The FDA product code for COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT is JSS.

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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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