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FDA 510(k)

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

K-Number: K890768 · 1989-03-21

ApplicantGenetic Systems Corp.
Decision Date1989-03-21
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Systems Corp.. It received FDA 510(k) clearance on 1989-03-21 under 510(k) number K890768. 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 PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT?

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT is a medical device that received FDA 510(k) clearance on 1989-03-21. The listed applicant is Genetic Systems Corp.. The 510(k) number is K890768.

When did PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT receive FDA 510(k) clearance?

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT received FDA 510(k) clearance on 1989-03-21, under 510(k) number K890768.

Who is the listed applicant for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT?

The FDA 510(k) record lists Genetic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT?

The FDA product code for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT is LYF.

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Other records listing Genetic Systems Corp. 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.

K891767GENETIC SYSTEMS MICROPLATE READERK891768GENETIC SYSTEMS MICROPLATE WASHERK891765GENETIC SYSTEMS PIPETTOR/DILUTORK891766GENETIC SYSTEMS MICROPLATE STRIP WASHERK873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDESK873542MICROPLATE AUTO-WASHER (MOTORIZED STAGE)

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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.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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