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FDA 510(k)

LYFO(TM) DIFFERIENTAL DISK-PYR

K-Number: K954812 · 1995-12-20

ApplicantMicrobiologics, Inc.
Decision Date1995-12-20
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYFO(TM) DIFFERIENTAL DISK-PYR is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K954812. 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 LYFO(TM) DIFFERIENTAL DISK-PYR?

LYFO(TM) DIFFERIENTAL DISK-PYR is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Microbiologics, Inc.. The 510(k) number is K954812.

When did LYFO(TM) DIFFERIENTAL DISK-PYR receive FDA 510(k) clearance?

LYFO(TM) DIFFERIENTAL DISK-PYR received FDA 510(k) clearance on 1995-12-20, under 510(k) number K954812.

Who is the listed applicant for LYFO(TM) DIFFERIENTAL DISK-PYR?

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

What is the FDA product code for LYFO(TM) DIFFERIENTAL DISK-PYR?

The FDA product code for LYFO(TM) DIFFERIENTAL DISK-PYR 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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