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FDA 510(k)

PYR TEST KIT

K-Number: K931865 · 1993-12-15

ApplicantHardy Diagnostics
Decision Date1993-12-15
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1993-12-15 under 510(k) number K931865. 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 PYR TEST KIT?

PYR TEST KIT is a medical device that received FDA 510(k) clearance on 1993-12-15. The listed applicant is Hardy Diagnostics. The 510(k) number is K931865.

When did PYR TEST KIT receive FDA 510(k) clearance?

PYR TEST KIT received FDA 510(k) clearance on 1993-12-15, under 510(k) number K931865.

Who is the listed applicant for PYR TEST KIT?

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 PYR TEST KIT?

The FDA product code for PYR TEST KIT is JTO.

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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