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FDA 510(k)

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII

K-Number: K905504 · 1991-06-28

ApplicantDako Corp.
Decision Date1991-06-28
Product CodeLYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K905504. 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 STAINING SYSTEM FOR PNEUMOCYSTIS CARINII?

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Dako Corp.. The 510(k) number is K905504.

When did STAINING SYSTEM FOR PNEUMOCYSTIS CARINII receive FDA 510(k) clearance?

STAINING SYSTEM FOR PNEUMOCYSTIS CARINII received FDA 510(k) clearance on 1991-06-28, under 510(k) number K905504.

Who is the listed applicant for STAINING SYSTEM FOR PNEUMOCYSTIS CARINII?

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

What is the FDA product code for STAINING SYSTEM FOR PNEUMOCYSTIS CARINII?

The FDA product code for STAINING SYSTEM FOR PNEUMOCYSTIS CARINII is LYF.

Related Clinical Trials

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Other records listing Dako 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.

K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGK993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTORK991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1K991454MOUSE IGG1 NEGATIVE CONTROLSK980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING

View all 54 devices →

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.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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