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FDA 510(k)

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

K-Number: K884047 · 1989-03-14

ApplicantDisease Detection International, Inc.
Decision Date1989-03-14
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K884047. 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 FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY?

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K884047.

When did FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY receive FDA 510(k) clearance?

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY received FDA 510(k) clearance on 1989-03-14, under 510(k) number K884047.

Who is the listed applicant for FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY?

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

What is the FDA product code for FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY?

The FDA product code for FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY is LYF.

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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.K904400MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONMeridian Diagnostics, Inc.K890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.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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