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FDA 510(k)

SENSITITRE INDOLE REAGENT

K-Number: K894776 · 1989-08-31

ApplicantRadiometer America, Inc.
Decision Date1989-08-31
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE INDOLE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1989-08-31 under 510(k) number K894776. 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 SENSITITRE INDOLE REAGENT?

SENSITITRE INDOLE REAGENT is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Radiometer America, Inc.. The 510(k) number is K894776.

When did SENSITITRE INDOLE REAGENT receive FDA 510(k) clearance?

SENSITITRE INDOLE REAGENT received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894776.

Who is the listed applicant for SENSITITRE INDOLE REAGENT?

The FDA 510(k) record lists Radiometer America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSITITRE INDOLE REAGENT?

The FDA product code for SENSITITRE INDOLE 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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