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FDA 510(k)

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

K-Number: K904400 · 1990-10-16

ApplicantMeridian Diagnostics, Inc.
Decision Date1990-10-16
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K904400. 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 MERIFLUOR TM PNEUMOCYSTIS MODIFICATION?

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K904400.

When did MERIFLUOR TM PNEUMOCYSTIS MODIFICATION receive FDA 510(k) clearance?

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION received FDA 510(k) clearance on 1990-10-16, under 510(k) number K904400.

Who is the listed applicant for MERIFLUOR TM PNEUMOCYSTIS MODIFICATION?

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

What is the FDA product code for MERIFLUOR TM PNEUMOCYSTIS MODIFICATION?

The FDA product code for MERIFLUOR TM PNEUMOCYSTIS MODIFICATION is LYF.

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Other records listing Meridian Diagnostics, 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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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.K923349FUNGI FLUOR KITPolysciences, Inc.K905504STAINING SYSTEM FOR PNEUMOCYSTIS CARINIIDako Corp.K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.K884047FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAYDisease Detection International, Inc.K881608MERIFLUOR(TM) PNEUMOCYSTISMeridian Diagnostics, 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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