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FDA 510(k)

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

K-Number: K992252 · 1999-08-10

ApplicantChemicon Intl., Inc.
Decision Date1999-08-10
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 is the device name listed in this FDA 510(k) record. The listed applicant is Chemicon Intl., Inc.. It received FDA 510(k) clearance on 1999-08-10 under 510(k) number K992252. 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 LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965?

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Chemicon Intl., Inc.. The 510(k) number is K992252.

When did LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 receive FDA 510(k) clearance?

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 received FDA 510(k) clearance on 1999-08-10, under 510(k) number K992252.

Who is the listed applicant for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965?

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

What is the FDA product code for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965?

The FDA product code for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 is LYF.

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Other records listing Chemicon Intl., Inc. as applicant

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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.

K923349FUNGI FLUOR KITPolysciences, 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

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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