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FDA 510(k)

INDOLE SPOT & INDOLE KOVACS REAGENT

K-Number: K930718 · 1993-04-23

ApplicantHardy Diagnostics
Decision Date1993-04-23
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDOLE SPOT & INDOLE KOVACS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K930718. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDOLE SPOT & INDOLE KOVACS REAGENT?

INDOLE SPOT & INDOLE KOVACS REAGENT is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Hardy Diagnostics. The 510(k) number is K930718.

When did INDOLE SPOT & INDOLE KOVACS REAGENT receive FDA 510(k) clearance?

INDOLE SPOT & INDOLE KOVACS REAGENT received FDA 510(k) clearance on 1993-04-23, under 510(k) number K930718.

Who is the listed applicant for INDOLE SPOT & INDOLE KOVACS REAGENT?

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

What is the FDA product code for INDOLE SPOT & INDOLE KOVACS REAGENT?

The FDA product code for INDOLE SPOT & INDOLE KOVACS REAGENT is JTO.

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Related Devices (Code: JTO)

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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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