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FDA 510(k)

FUNGI FLUOR KIT

K-Number: K923349 · 1992-10-20

ApplicantPolysciences, Inc.
Decision Date1992-10-20
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FUNGI FLUOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Polysciences, Inc.. It received FDA 510(k) clearance on 1992-10-20 under 510(k) number K923349. The device is classified under product code LYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUNGI FLUOR KIT?

FUNGI FLUOR KIT is a medical device that received FDA 510(k) clearance on 1992-10-20. The listed applicant is Polysciences, Inc.. The 510(k) number is K923349.

When did FUNGI FLUOR KIT receive FDA 510(k) clearance?

FUNGI FLUOR KIT received FDA 510(k) clearance on 1992-10-20, under 510(k) number K923349.

Who is the listed applicant for FUNGI FLUOR KIT?

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

What is the FDA product code for FUNGI FLUOR KIT?

The FDA product code for FUNGI FLUOR KIT is LYF.

Related Clinical Trials

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.

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Other records listing Polysciences, Inc. as applicant

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.

K871290CENTRICELL(TM)K780146T3 STI KIT

Related Devices (Code: LYF)

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.

K992252LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965Chemicon Intl., Inc.K905504STAINING SYSTEM FOR PNEUMOCYSTIS CARINIIDako Corp.K904400MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONMeridian Diagnostics, Inc.K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.K884047FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAYDisease Detection International, Inc.K881608MERIFLUOR(TM) PNEUMOCYSTISMeridian Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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